MAUDE Adverse Event Report: REFER TO SECTION H10 DELTAPAQ CERE 3MMX10CM; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number CDF10031030

Device Problems Premature Activation (1484); Stretched (1601)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/28/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Information regarding patient age, gender, weight, medical history, race, and ethnicity were not provided.The event occurred in the year of 2018; however, the month and day are were not provided.Procode: krd/hcg.(b)(4).The product has not been returned for evaluation and testing.Additional information will be submitted within 30 days upon receipt.Initial reporter - the contact name provided is the distributor (b)(4); the facility name was not provided (b)(4).The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.

Event Description

A report was received that during a coil embolization of a left maxillary artery aneurysm, the 3 mm x 10 cm deltapaq (cdf10031030/p11731) thermo-mechanical coil delivery system was introduced into the patient and while being positioned at the target vessel, the coil was noted to be stretched.There was no report of patient injury.It was not reported if the product will be returned for evaluation.No further information was provided.

Manufacturer Narrative

(b)(4).Race: caucasian.Additional information received indicated that the coil stretched after its detachment with specific device and a segment of the coil was trapped inside of the microcatheter.This issue required removal and disposal of the coil.The intended procedure was a coil embolization of an occlusion in the internal jaw.The patient was in the preoperative period for temporomandibular joint ankylotic mass resection.Neck remodeling was not used.An adequate continuous flush was not maintained through the unspecified microcatheter.There was no resistance encountered between the guidewire and microcatheter when accessing the target site.There was also no resistance felt during advancement of the coil through the microcatheter.One coil was used prior to this coil.There were no kinks in the microcatheter that may have contributed to the reported event.Reportedly, there was no difficulty encountered while positioning the coil in the target site.The coil conformed to the walls of the aneurysm.The coil did not protrude out of the aneurysm during positioning prior to detachment.The microcatheter was repositioned over the coil while the coil was deployed or partially deployed out of the distal end of the microcatheter.A one-to-one relationship between the coil and delivery tube was verified with fluoroscopy prior to repositioning.The microcoil was positioned at a relative sharp angle to the microcatheter.The suspected cause of the coil stretch was ¿failure to post¿.Coil entanglement with previously placed coils was not suspected.The coil was successfully removed from the patient.The coil was removed with the microcatheter as a unit.The coil was still attached to the delivery system when removed.No additional damages were noted to the device after removal.The microcatheter was not used to complete the case.The user did not apply excessive force at any time during the procedure.No patient complications occurred as a result of the event.There was no evidence of flow restriction/reduction.There was no clinically significant delay in the procedure due to the event.The complaint product was discarded and is thus not available for return.Additional information will be submitted within 30 days of receipt.Initial reporter facility name due to character limitation: (b)(6).The product was discarded by the site and is thus not available for evaluation and testing.A review of the manufacturing documentation associated with this lot presented no issues during the manufacturing or inspection process that can be related to the reported complaint.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.

Manufacturer Narrative

Product complaint # (b)(4).Complaint conclusion: as reported by a healthcare professional, during a coil embolization of a left maxillary artery aneurysm, the 3mm x 10cm deltapaq (cdf10031030/p11731) thermo-mechanical coil delivery system was introduced into the patient and while being positioned at the target vessel, the coil was noted to be stretched.Additional information received indicated that the coil stretched after its detachment with specific device and a segment of the coil was trapped inside of the microcatheter.The coil was removed with the microcatheter as a unit.The coil was successfully removed from the patient and the coil was still attached to the delivery system when removed.No additional damages were noted to the device after removal.The microcatheter was not used to complete the case.No patient complications occurred as a result of the event.There was no evidence of flow restriction/reduction and no clinically significant delay in the procedure due to the event.An adequate continuous flush was not maintained through the unspecified microcatheter.There was no resistance encountered between the guidewire and microcatheter when accessing the target site.There was also no resistance felt during advancement of the coil through the microcatheter.One coil was used prior to this coil.There were no kinks in the microcatheter that may have contributed to the reported event.Reportedly, there was no difficulty encountered while positioning the coil in the target site.The coil conformed to the walls of the aneurysm.The coil did not protrude out of the aneurysm during positioning prior to detachment.The microcatheter was repositioned over the coil while the coil was deployed or partially deployed out of the distal end of the microcatheter.A one-to-one relationship between the coil and delivery tube was verified with fluoroscopy prior to repositioning.The microcoil was positioned at a relative sharp angle to the microcatheter.The suspected cause of the coil stretch was ¿failure to post¿.Coil entanglement with previously placed coils was not suspected.The user did not apply excessive force at any time during the procedure.The patient was in the preoperative period for temporomandibular joint ankylotic mass resection.The target vessel was an occlusion of the internal jaw.Neck remodeling was not utilized.Multiple attempts to obtain clarification were unsuccessful.The deltapaq cere was not returned for investigation.A review of manufacturing documentation associated with this lot presented no issues during the manufacturing or inspection processes related to the reported complaint.Positioning difficulty, coil stretching, and premature detachment are known potential issues associated with the deltapaq and coil embolization procedures.With the limited information available and without the product and concomitant microcatheter available for analysis, the reported customer complaint could not be confirmed.Based on the device history record review, there is no indication that the event is related to the device manufacturing process.The event description indicates that the microcoil was positioned at a relative sharp angle to the microcatheter.The instructions for use (ifu) cautions that if the microcoil is positioned at a relative sharp angle to the microcatheter, a microcoil may stretch or break as it is being withdrawn.By repositioning 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.The ifu also states: ¿never advance, withdraw, or torque the delivery tube against resistance without first determining the cause of resistance under fluoroscopy.Manipulation of the delivery tube against resistance can cause damage and/or premature detachment of the coil.If unusual friction is noted within the infusion catheter, remove the detachable coil system.If coil repositioning is required, gently withdraw and then re-advance the coil.¿ the exact cause of the event could not be conclusively determined; however, it is possible that clinical/procedural factors, vessel/target site angulation, and the concomitant microcatheter may have contributed to the reported event.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.

• Brand Name: DELTAPAQ CERE 3MMX10CM
• Type of Device: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): REFER TO SECTION H10; 47709 fremont blvd; fremont CA 94538
• MDR Report Key: 7352858
• MDR Text Key: 103279281
• Report Number: 3008114965-2018-00576
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00878528007210
• UDI-Public: 00878528007210
• Combination Product (y/n): N
• PMA/PMN Number: K080437
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup,Followup
• Report Date: 03/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2021
• Device Catalogue Number: CDF10031030
• Device Lot Number: P11731
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 48 YR
• Patient Weight: 70