MAUDE Adverse Event Report: SEE H.10 CASH 14 CERE 4MMX4.5CM; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	CRC14044530
Medical Device Problem Codes	Separation Failure (2547); Premature Separation (4045)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	02/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturer¿s ref.No.: (b)(4).Information regarding patient identifier, date of birth, age, gender, weight, race, ethnicity, and medical history were not provided.Physical manufacturer name: codman and shurtleff inc., dba depuy synthes products, inc.((b)(4)).(b)(4).[conclusion]: the healthcare professional reported that during the procedure to treat a 4 mm aneurysm on the anterior communicating artery (acom), the 4 mm x 4.5 cm cashmere 14 cerecyte coil (crc14044530 / c26712) passed the fault light test, was flushed and delivered through the sl-10® microcatheter (stryker) and deployed at the target aneurysm but failed to detach after the first detach cycle.There were two more detachment cycles performed without success.The physician then slightly manipulated the coil and cycle through another detachment cycle without success.This technique of slightly manipulating the coil was employed two more times without success.In all, there were a total of 6 detachment cycles attempted with the coil failing to detach.The physician then attempted to remove the coil from the aneurysm.Upon retracing the coil 1 cm back into the microcatheter, the coil detached from the pusher wire.The physician then used the pusher wire to push the coil back into the aneurysm with success.A 2.5 cm x 4 mm target® nano¿ coil (stryker) was then deployed and detached into the aneurysm without incident.At this point, the case was concluded.There was no report of patient complications or adverse event associated with the reported incident.The cashmere 14 cerecyte coil remains implanted and is thus, not available to be returned for evaluation and analysis.Failure to detach and premature detachment are known procedural issues related to the cashmere coils.Based on the minimal information provided, it is not possible to determine the root cause of the detachment issue.It is unknown if the connecting cable (cc) or detachment control box (dcb) were replaced during the procedure.Factors that can contributed to failure to detach include failure to confirm secure connection of the cable to the dpu and dcb.If after depressing the detach button on the dcb, the dcb should be replaced if the light and audible tone do not activate.Also, if the system ready light is not illuminated and there is no detachment after two detachment attempts, the dcb should be replaced.If detachment still does not occur, the microcoil system should be carefully withdrawn and replaced.If the microcoil is positioned at a relative sharp angle to the microcatheter, the coil may stretch or break as it is being withdrawn.By positioning the distal tip of the catheter at or slightly inside the ostium of the aneurysm, the microcoil may be more easily funneled back into the microcatheter.Since failure to detach and premature detachment could potentially result in serious injury, they are mdr reportable as a malfunction; however, since additional intervention of pushing the coil back into the aneurysm was necessary, the complaint meets reportability as a serious injury.Based on complaint information, the 4 mm x 4.5 cm cashmere 14 cerecyte coil remains implanted and is thus not available for evaluation.Product analysis cannot be conducted as the product was not returned for analysis.No determination of causes and possible contributing factors could be made.As such, the investigation will be closed.A review of manufacturing documentation associated with this lot (c26712) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformances related to device manufacture or inspection.With the information provided in the complaint and without the product available to be returned for evaluation and analysis, the reported issue that the coil failed to detach after a total of 6 attempted detachment cycles then became detached during the attempt to remove the coil could not be confirmed through analysis.Based on the device history record review, there is no indication that the event is related to the device manufacturing process.Assignment of root cause for the event remains speculative and inconclusive, based on the limited information provided and without the return of the complaint sample; however, it is possible that clinical and procedural factors, including device manipulation/interaction may have contributed to the reported failure.As part of the post market surveillance program, information from this complaint is trended for statistical signals and corrective/preventive action may be triggered at a later time.Since there was no evidence to suggest the event was related to a manufacturing or design issue, no corrective actions will be taken at this time.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.
Event or Problem Description
The healthcare professional reported that during the procedure to treat a 4 mm aneurysm on the anterior communicating artery (acom), the 4 mm x 4.5 cm cashmere 14 cerecyte coil (crc14044530 / c26712) passed the fault light test, was flushed and delivered through the sl-10® microcatheter (stryker) and deployed at the target aneurysm but failed to detach after the first detach cycle.There were two more detachment cycles performed without success.The physician then slightly manipulated the coil and cycle through another detachment cycle without success.This technique of slightly manipulating the coil was employed two more times without success.In all, there were a total of 6 detachment cycles attempted with the coil failing to detach.The physician then attempted to remove the coil from the aneurysm.Upon retracing the coil 1 cm back into the microcatheter, the coil detached from the pusher wire.The physician then used the pusher wire to push the coil back into the aneurysm with success.A 2.5 cm x 4 mm target® nano¿ coil (stryker) was then deployed and detached into the aneurysm without incident.At this point, the case was concluded.There was no report of patient complications or adverse event associated with the reported incident.The cashmere 14 cerecyte coil remains implanted and is thus, not available to be returned for evaluation and analysis.
Additional Manufacturer Narrative
Manufacturer¿s ref.No.: (b)(4).The purpose of this mdr is to include the additional event information received on 2/25/2019.[conclusion]: the healthcare professional reported that during the procedure to treat a 4 mm aneurysm on the anterior communicating artery (acom), the 4 mm x 4.5 cm cashmere 14 cerecyte coil (crc14044530 / c26712) passed the fault light test, was flushed and delivered through the sl-10® microcatheter (stryker) and deployed at the target aneurysm but failed to detach after the first detach cycle.Enpower detachment control box (dcb00000500 / lot# unk) and enpower control cable (ecb00018200 / lot# unk) were used.There were two more detachment cycles performed without success.It was confirmed that the green system ready light was illuminated and during the detachment cycle, the detachment light illuminated, and the audible signal beep was heard.The physician then slightly manipulated the coil and cycle through another detachment cycle without success.This technique of slightly manipulating the coil was employed two more times without success.In all, there were a total of 6 detachment cycles attempted with the coil failing to detach.The physician then attempted to remove the coil from the aneurysm.Upon retracing the coil 1 cm back into the microcatheter, the coil detached from the pusher wire.The physician then used the pusher wire to push the coil back into the aneurysm with success.A 2.5 cm x 4 mm target® nano¿ coil (stryker) was then deployed and detached into the aneurysm without incident.At this point, the case was concluded.It was confirmed that a pre-deployment electrical check was performed.The low battery light was not seen during the case.All connections appeared to fit properly without application of excessive force.The enpower dcb and the control cable were used to detach subsequent coils.There was no report of patient complications or adverse event associated with the reported incident.The reported event did not result in any clinically significant delay in the procedure.The cashmere 14 cerecyte coil remains implanted and is thus, not available to be returned for evaluation and analysis.Failure to detach and premature detachment are known procedural issues related to the cashmere coils.Based on the minimal information provided, it is not possible to determine the root cause of the detachment issue.It is unknown if the connecting cable (cc) or detachment control box (dcb) were replaced during the procedure.Factors that can contributed to failure to detach include failure to confirm secure connection of the cable to the dpu and dcb.If after depressing the detach button on the dcb, the dcb should be replaced if the light and audible tone do not activate.Also, if the system ready light is not illuminated and there is no detachment after two detachment attempts, the dcb should be replaced.If detachment still does not occur, the microcoil system should be carefully withdrawn and replaced.If the microcoil is positioned at a relative sharp angle to the microcatheter, the coil may stretch or break as it is being withdrawn.By positioning the distal tip of the catheter at or slightly inside the ostium of the aneurysm, the microcoil may be more easily funneled back into the microcatheter.Since failure to detach and premature detachment could potentially result in serious injury, they are mdr reportable as a malfunction; however, since additional intervention of pushing the coil back into the aneurysm was necessary, the complaint meets reportability as a serious injury.Based on complaint information, the 4 mm x 4.5 cm cashmere 14 cerecyte coil remains implanted and is thus not available for evaluation.Product analysis cannot be conducted as the product was not returned for analysis.No determination of causes and possible contributing factors could be made.As such, the investigation will be closed.A review of manufacturing documentation associated with this lot (c26712) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformances related to device manufacture or inspection.With the information provided in the complaint and without the product available to be returned for evaluation and analysis, the reported issue that the coil failed to detach after a total of 6 attempted detachment cycles then became detached during the attempt to remove the coil could not be confirmed through analysis.Based on the device history record review, there is no indication that the event is related to the device manufacturing process.Assignment of root cause for the event remains speculative and inconclusive, based on the limited information provided and without the return of the complaint sample; however, it is possible that clinical and procedural factors, including device manipulation/interaction may have contributed to the reported failure.As part of the post market surveillance program, information from this complaint is trended for statistical signals and corrective/preventive action may be triggered at a later time.Since there was no evidence to suggest the event was related to a manufacturing or design issue, no corrective actions will be taken at this time.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.Updated sections: g.4, g.7, h.2, and h.10.

• Brand Name: CASH 14 CERE 4MMX4.5CM
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): SEE H.10; 47709 fremont blvd; fremont CA 94538
• MDR Report Key: 8362195
• Report Number: 3008114965-2019-00909
• Device Sequence Number: 19291034
• Product Code: HCG
• UDI-Device Identifier: 00878528004455
• UDI-Public: 00878528004455
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K072173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2019
• Device Catalogue Number: CRC14044530
• Device Lot Number: C26712
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/06/2019
• Supplement Date Received by Manufacturer: 02/25/2019
• Initial Report FDA Received Date: 02/22/2019
• Supplement Report FDA Received Date: 03/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SL-10® MICROCATHETER (STRYKER); SL-10® MICROCATHETER (STRYKER)
• Outcome Attributed to Adverse Event: Other