MAUDE Adverse Event Report: SEE H.10 DELTAFILL18 16MM X 50CM; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	DLF181650
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/22/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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)).Concomitant med products: progreat alpha¿ (terumo) peripheral microcatheter.Initial reporter information such as the first name and email address are not available / unknown.[conclusion]: the healthcare professional reported that during the type ii endoleak coil embolization procedure to treat an aneurysm at the internal mesenteric artery, accessing from the right femoral artery approaching from the superior mesenteric artery (sma) to the inferior mesenteric artery (ima).The catheter was advanced through the sma to the target lesion at the ima.The coiling portion of the procedure started with the progreat alpha¿ (terumo) peripheral microcatheter and the seven (7) deltafill 18 coils were implanted at the target lesion.When the 8th deltafill 18 16mm x 50cm coil (dlf181650 / l13397) was inserted, the coil did not completely come out of the distal end of the microcatheter.There was resistance between the microcatheter and the delivery wire.The physician decided to resheath the coil and the coil became prematurely deployed inside the microcatheter.The physician used the delivery wire and the guidewire (chikai, asahi intecc) to push the prematurely deployed coil inside the microcatheter in attempt to get the coil implanted, but the coil remained inside the microcatheter and the physician had to withdraw the microcatheter with the prematurely deployed deltafill 18 inside.The coil came out of the microcatheter during the withdrawal of the microcatheter.A new microcatheter was used and the deltafill 18 16mm x 50cm coil was successfully implanted in the target lesion through the new microcatheter.The procedure was successfully completed with ten (10) other galaxy coils without any further issues or delay.There was no report of patient injury or complication; the complaint product was new and was stored per labeling instructions.The procedure was conducted in accordance with the instruction for use (ifu) with constant flush maintained at all time.There was no visible defect or damage noted on the product prior to the event.There was no unintended detachment observed in the vessel or in the microcatheter.It was reported that the product was implanted and is thus not available for evaluation.Based on complaint information, the device was not available to be returned for analysis.A review of manufacturing documentation associated with this lot (l13397) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no non-conformances related to device manufacture or inspection.All product rejected during manufacturing was identified as scrap and properly accounted for.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.Premature deployment/detachment in the microcatheter is a known potential issue associated with the use of the device.With the information provided in the complaint and without the product available for analysis, the reported issues by the customer cannot be confirmed.Based on the device history record review, there is no indication that the event is related to the device manufacturing process.The exact cause of the premature deployment inside the microcatheter could not be conclusively determined.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 the circumstances of the procedure and/or the manipulation and interaction of the devices such as the reported resistance that was felt between the microcatheter and the delivery wire that prompted the physician to decide to resheath the deltafill 18 16mm x 50cm coil.The resistance experienced and the subsequent attempt to resheath the coil may have contributed to the premature deployment of the coil inside the progreat alpha¿ (terumo) peripheral microcatheter.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 type ii endoleak coil embolization procedure to treat an aneurysm at the internal mesenteric artery, accessing from the right femoral artery approaching from the superior mesenteric artery (sma) to the inferior mesenteric artery (ima).The catheter was advanced through the sma to the target lesion at the ima.The coiling portion of the procedure started with the progreat alpha¿ (terumo) peripheral microcatheter and the seven (7) deltafill 18 coils were implanted at the target lesion.When the 8th deltafill 18 16mm x 50cm coil (dlf181650 / l13397) was inserted, the coil did not completely come out of the distal end of the microcatheter.There was resistance between the microcatheter and the delivery wire.The physician decided to resheath the coil and the coil became prematurely deployed inside the microcatheter.The physician used the delivery wire and the guidewire (chikai, asahi intecc) to push the prematurely deployed coil inside the microcatheter in attempt to get the coil implanted, but the coil remained inside the microcatheter and the physician had to withdraw the microcatheter with the prematurely deployed deltafill 18 inside.The coil came out of the microcatheter during the withdrawal of the microcatheter.A new microcatheter was used and the deltafill 18 16mm x 50cm coil was successfully implanted in the target lesion through the new microcatheter.The procedure was successfully completed with ten (10) other galaxy coils without any further issues or delay.There was no report of patient injury or complication; the complaint product was new and was stored per labeling instructions.The procedure was conducted in accordance with the instruction for use (ifu) with constant flush maintained at all time.There was no visible defect or damage noted on the product prior to the event.There was no unintended detachment observed in the vessel or in the microcatheter.It was reported that the product was implanted and is thus not available for evaluation.
Additional Manufacturer Narrative
(b)(4).The purpose of this mdr is to include the additional event information received on 1/6/2019.[conclusion]: the healthcare professional reported that during the type ii endoleak coil embolization procedure to treat an aneurysm at the internal mesenteric artery, accessing from the right femoral artery approaching from the superior mesenteric artery (sma) to the inferior mesenteric artery (ima).The catheter was advanced through the sma to the target lesion at the ima.The coiling portion of the procedure started with the progreat alpha¿ (terumo) peripheral microcatheter and the seven (7) deltafill 18 coils were implanted at the target lesion.When the 8th deltafill 18 16mm x 50cm coil (b)(4) was inserted, the coil did not completely come out of the distal end of the microcatheter.There was resistance between the microcatheter and the delivery wire.The physician decided to resheath the coil and the coil became prematurely deployed inside the microcatheter.The physician used the delivery wire and the guidewire (chikai, asahi intecc) to push the prematurely deployed coil inside the microcatheter in attempt to get the coil implanted, but the coil remained inside the microcatheter and the physician had to withdraw the microcatheter with the prematurely deployed deltafill 18 inside.The coil came out of the microcatheter during the withdrawal of the microcatheter.A new microcatheter was used and the deltafill 18 16mm x 50cm coil was successfully implanted in the target lesion through the new microcatheter.The procedure was successfully completed with ten (10) other galaxy coils without any further issues or delay.There was no report of patient injury or complication; the complaint product was new and was stored per labeling instructions.The procedure was conducted in accordance with the instruction for use (ifu) with constant flush maintained at all time.There was no visible defect or damage noted on the product prior to the event.There was no unintended detachment observed in the vessel or in the microcatheter.It was reported that the product was implanted and is thus not available for evaluation.No further information was available per the affiliate.Based on complaint information, the device was not available to be returned for analysis.A review of manufacturing documentation associated with this lot (l13397) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no non-conformances related to device manufacture or inspection.All product rejected during manufacturing was identified as scrap and properly accounted for.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.Premature deployment/detachment in the microcatheter is a known potential issue associated with the use of the device.With the information provided in the complaint and without the product available for analysis, the reported issues by the customer cannot be confirmed.Based on the device history record review, there is no indication that the event is related to the device manufacturing process.The exact cause of the premature deployment inside the microcatheter could not be conclusively determined.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 the circumstances of the procedure and/or the manipulation and interaction of the devices such as the reported resistance that was felt between the microcatheter and the delivery wire that prompted the physician to decide to resheath the deltafill 18 16mm x 50cm coil.The resistance experienced and the subsequent attempt to resheath the coil may have contributed to the premature deployment of the coil inside the progreat alpha¿ (terumo) peripheral microcatheter.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.Missing information from this report is identified as blank; this information was not provided in the reported event or available at the time of report submission.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.

• Brand Name: DELTAFILL18 16MM X 50CM
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): SEE H.10; 47709 fremont blvd; fremont CA 94538
• MDR Report Key: 8139827
• Report Number: 3008114965-2018-00816
• Device Sequence Number: 13845278
• Product Code: KRD
• UDI-Device Identifier: 10886704077145
• UDI-Public: 10886704077145
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K150319
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2021
• Device Catalogue Number: DLF181650
• Device Lot Number: L13397
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/22/2018
• Supplement Date Received by Manufacturer: 01/06/2019
• Initial Report FDA Received Date: 12/06/2018
• Supplement Report FDA Received Date: 01/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1