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

Model Number CPL100151-30

Device Problem Positioning Problem (3009)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/20/2020

Event Type  malfunction  

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The device is available to be returned for evaluation and testing.However, it has not been received to date as indicated as ¿other¿ in this section as the reason for non-evaluation.If the device returns, a device investigation will be performed.A review of manufacturing documentation associated with this lot (c38361) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformances related to device manufacture or inspection.All product rejected during manufacturing was identified as scrap and properly accounted for.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 Description

The healthcare professional reported that the 1.5mm x 1cm deltaplush 10 cerecyte coil (cpl10015130 / c38361) was chosen as the finishing coil for the procedure; it was reported that the physician did not like the shape of the coil deployment and decided to remove the coil.During the resheathing attempt, the coil introducer failed to be re-zipped.The physician used another 1.5mm x 1cm deltaplush 10 cerecyte coil and the procedure was successfully completed.There was no report of any patient adverse event or complication.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to report that the product analysis lab received the returned complaint device on 09/01/2020; the returned product underwent evaluation and analysis.[conclusion]: the healthcare professional reported that the 1.5mm x 1cm deltaplush 10 cerecyte coil (cpl10015130 / c38361) was chosen as the finishing coil for the procedure; it was reported that the physician did not like the shape of the coil deployment and decided to remove the coil.During the resheathing attempt, the coil introducer failed to be re-zipped.The physician used another 1.5mm x 1cm deltaplush 10 cerecyte coil and the procedure was successfully completed.There was no report of any patient adverse event or complication.Multiple attempts to obtain additional information related to the procedure and the reported device issue were unsuccessful.If additional information is received at a later date, this file will be updated accordingly.The device was returned for evaluation and analysis.The investigational finding is documented below.Investigation summary: the non-sterile 1.5mm x 1cm deltaplush 10 cerecyte coil was returned contained in a pouch.Visual inspection was performed.The inroducer has a kink at the strain relief section.The device positioning unit (dpu) was observed protruding from the introducer.No other damage or abnormality was observed.Microscopic inspection was performed.The embolic coil was observed in good normal condition.Functional evaluation was not conducted due to the condition of the dpu; the dpu is protruding from the introducer.A review of manufacturing documentation associated with this lot (c38361) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformances related to device manufacture or inspection.All product rejected during manufacturing was identified as scrap and properly accounted for.The issue documented in the complaint is that the the physician chose the 1.5mm x 1cm deltaplush 10 cerecyte coil as the finishing coil, but did not like the shape of the coil deployment and removed the coil; during the attempt to re-zip the coil, the introducer failed to be re-zipped.This issue was confirmed based on the observation during the visual inspection that the dpu is protruding from the introducer.The reported issue related to the re-zipping failure was confirmed.The protruding dpu from the coil introducer would preclude the introducer from being re-zipped.The likely cause of the kinks observed near the strain relief section of the introducer and on the dpu is likely force.During procedural handling, force may have been applied during the attempt to resheath the coil may have resulted in the observed kinked sections on the returned device.Positioning difficulty / poor conformability is a known potential issue associated with the use of the device.Factors such as the shape of the target lesion, tortuosity of the parent vessel may have contributed to the way the coil is positioned and / or conforms when it gets delivered to the target site.Based on the manufacturing documentation review, there is no indication that the event is related to the device manufacturing process.It is possible that clinical and procedural factors, including device manipulation / interaction, aneurysm size / vessel characteristics, device selection, and the concomitant microcatheter, may have contributed to the reported positioning issue / poor conformability of the coil.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.

• Brand Name: DELTAPL CERE COIL 10 SYS 1.5X1
• Type of Device: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel CH-24 00; SZ CH-2400
• MDR Report Key: 10393925
• MDR Text Key: 228353094
• Report Number: 3008114965-2020-00293
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00878528008163
• UDI-Public: 00878528008163
• Combination Product (y/n): N
• PMA/PMN Number: K083646
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2020
• Device Model Number: CPL100151-30
• Device Catalogue Number: CPL10015130
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2020
• Date Manufacturer Received: 09/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1