MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL DELTAPL CERE COIL 10 SYS 1.5X1; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	CPL10015130
Medical Device Problem Code	Stretched (1601)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/17/2019
Type of Reportable Event	Malfunction
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.The name, phone and email address of the initial reporter are not available / reported.Physical manufacturer name: codman and shurtleff inc., dba depuy synthes products, inc.(b)(4).[conclusion]: the healthcare professional reported that the 1.5mm x 1cm deltaplush 10 cerecyte coil (cpl10015130 / s14368) was the first coil used during the procedure.The physician reported that strong resistance was felt during the advancement of the coil through the prowler microcatheter (unknown catalog/lot number) at the distal area of the microcatheter.The coil was replaced, and the procedure was successfully completed.There was no report of any patient adverse event or complication.The product was returned for evaluation.The investigational finding is documented below.Investigation summary: the non-sterile 1.5mm x 1cm deltaplush 10 cerecyte coil was received contained inside a pouch.Visual inspection was performed.The hub was inspected and was observed without any appearance of damage.The device positioning unit (dpu) was observed in good condition.The introducer was partially unzipped and kinked.The resheathing tool was in good condition.Microscopic inspection was performed.The v-notch was observed without any damage.The resistance heating (rh) was in good condition.The embolic coil was not detached but was observed in stretched condition.Functional testing could not be performed as the returned device could not undergo functional testing due to the kinked introducer and the stretched embolic coil.A review of manufacturing documentation associated with this lot (s14368) 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.The issue reported and documented in the complaint that the 1.5mm x 1cm deltaplush 10 cerecyte coil encountered strong resistance during the advancement of the coil through the microcatheter was not confirmed through functional testing as the condition of the returned device precluded it from undergoing functional evaluation.Coil stretching is known potential issue associated with the use of this device.The ifu provides proper handling instructions for the device to prevent such issue as stretching from occurring.The coil stretched condition was not originally reported in the complaint, however, the introducer was partially unzipped and kinked, an indication that force was likely the cause.It is possible that when the resistance issue was encountered during the coil advancement, force was inadvertently applied and that resulted in the kinked introducer.The coil could have become stretched during the attempt to withdraw the coil in order to attempt to advance the coil in the microcatheter.The exact cause of the stretched coil and the kinked introducer could not be conclusively determined.Based on the device history record review, there is no indication that the event is related to the device manufacturing process.In addition, devices undergo 100% inspection at final assembly for the condition of the embolic coil.Thus, it is not likely that the 1.5mm x 1cm deltaplush 10 cerecyte coil left the manufacturing facility with the embolic coil in a stretched condition.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 the 1.5mm x 1cm deltaplush 10 cerecyte coil (cpl10015130 / s14368) was the first coil used during the procedure.The physician reported that strong resistance was felt during the advancement of the coil through the prowler microcatheter (unknown catalog/lot number) at the distal area of the microcatheter.The coil was replaced, and the procedure was successfully completed.There was no report of any patient adverse event or complication.The 1.5mm x 1cm deltaplush 10 cerecyte coil was returned for evaluation which revealed that the embolic coil was stretched.Based on the product analysis on 10/23/2019, this event has been deemed mdr reportable as a ¿malfunction.¿.

• Brand Name: DELTAPL CERE COIL 10 SYS 1.5X1
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel CH-24 00; SZ CH-2400
• MDR Report Key: 9236164
• Report Number: 3008114965-2019-01216
• Device Sequence Number: 2233458
• Product Code: HCG
• UDI-Device Identifier: 00878528008163
• UDI-Public: 00878528008163
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K083646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/17/2019

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: 05/31/2022
• Device Catalogue Number: CPL10015130
• Device Lot Number: S14368
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/23/2019
• Initial Report FDA Received Date: 10/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1