MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL MSPHERE 10 CERE, 4MMX7.5CM; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	CSP10040030
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/17/2019
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.Physical manufacturer name: codman and shurtleff inc., dba depuy synthes products, inc.(b)(4).[conclusion]: the healthcare professional reported that during the procedure with the target site on the internal carotid artery (ica) while attempting to detach the 4mm x 7.5cm micrusphere 10 cerecyte coil (csp10040030 / s10465), the enpower detachment control box (dcb00000500 / c27718) did not work properly and the coil did not detach.The coil was removed still attached to the delivery system and not stretched.A pre-deployment check was performed and there was no issue noted during the check.There was no evidence of low battery, the box had been used with previous coils; the box had been used over the last several months without issue.The coil was replaced, and the same issue occurred.It was reported that the customer continued to use the dcb with three more coils because they had assumed the issue was related to the coils and not the box.The customer replaced the dcb and determined that the enpower detachment control box did not work properly and resulted in the failed detachment of the coils.This coil and the other three coils were not re-challenged after the detachment box was replaced.It was reported that the coil was discarded once it was determined that the issue was with the dcb not working properly.The procedure was completed without patient complication or procedural delay.Based on complaint information, the device was not available to be returned for analysis.A review of manufacturing documentation associated with this lot (s10465) 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.Failure to detach is a known potential product issue associated with the use of the device.The ifu contains several cautions relating to these situations, including instructions for troubleshooting should they be encountered during use.Per the ifu: ¿if a fault light is detected, the system ready light is not illuminated, or there is no detachment after two detachment attempts, replace the dcb unit.If detachment still does not occur, carefully withdraw the entire microcoil system and redeploy a new microcoil system.¿ the customer did determine the issue was related to the dcb and the dcb was replaced after three additional coils failed to detach.With the information provided in the complaint but without the 4mm x 7.5cm micrusphere 10 cerecyte coil being available for analysis, it could not be determined there was any detachment issue associated with the coil.Based on the device history record review, there is no indication that the event is related to the device manufacturing process.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.This is one of 4 products involved with the reported complaint.The associated manufacturer report numbers are 3008114965-2019-01037, 3008114965-2019-01038 and 3008114965-2019-01039.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 with the target site on the internal carotid artery (ica) while attempting to detach the 4mm x 7.5cm micrusphere 10 cerecyte coil (csp10040030 / s10465), the enpower detachment control box (dcb00000500 / c27718) did not work properly and the coil did not detach.The coil was removed still attached to the delivery system and not stretched.A pre-deployment check was performed and there was no issue noted during the check.There was no evidence of low battery, the box had been used with previous coils; the box had been used over the last several months without issue.The coil was replaced, and the same issue occurred.It was reported that the customer continued to use the dcb with three more coils because they had assumed the issue was related to the coils and not the box.The customer replaced the dcb and determined that the enpower detachment control box did not work properly and resulted in the failed detachment of the coils.This coil and the other three coils were not re-challenged after the detachment box was replaced.It was reported that the coil was discarded once it was determined that the issue was with the dcb not working properly.The procedure was completed without patient complication or procedural delay.

• Brand Name: MSPHERE 10 CERE, 4MMX7.5CM
• 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: 8680270
• Report Number: 3008114965-2019-01036
• Device Sequence Number: 19334373
• Product Code: HCG
• UDI-Device Identifier: 00878528001041
• UDI-Public: 00878528001041
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K0022420
• 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
• Report Date (Section B): 05/17/2019

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: 04/30/2021
• Device Catalogue Number: CSP10040030
• Device Lot Number: S10465
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/17/2019
• Initial Report FDA Received Date: 06/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1