MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL MICRUSFRAME18 8MM X 30CM; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	MFR180830
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/06/2019
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.Procode: krd/hcg.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 during the procedure, a pre-deployment electrical check was performed on the 9mm x 15.3cm micrusframe 18 coil (mfr180830 / l14779), but the green system ready light on the detachment control box did not illuminate.The coil was replaced with another micrusframe 18 coil of the same size and from the same lot number.The detachment control box was powered off and back on again before another pre-deployment electrical check was performed without any issue.The replacement coil was successfully used to complete the procedure.There was no report of any patient injury or complication due to the reported event.Based on complaint information, the device was not available to be returned for analysis.A review of manufacturing documentation associated with this lot (l14779) 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 issue associated with the use of this device.The instructions for use (ifu) contains several precautions related to this issue and includes instructions for troubleshooting the situation should it be encountered during use.With the limited information available and without the product 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.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 clinical and procedural factors, including device manipulation / interaction, aneurysm size / vessel characteristics, device selection, and the concomitant microcatheter, may have contributed to the reported failure.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 procedure, a pre-deployment electrical check was performed on the 9mm x 15.3cm micrusframe 18 coil (mfr180830 / l14779), but the green system ready light on the detachment control box did not illuminate.The coil was replaced with another micrusframe 18 coil of the same size and from the same lot number.The detachment control box was powered off and back on again before another pre-deployment electrical check was performed without any issue.The replacement coil was successfully used to complete the procedure.There was no report of any patient injury or complication due to the reported event.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).The purpose of this mdr is to include the additional event information received on 9/9/2019.[additional information]: the healthcare professional reported that during the procedure, a pre-deployment electrical check was performed on the 9mm x 15.3cm micrusframe 18 coil (mfr180830 / l14779), but the green system ready light on the detachment control box did not illuminate.It was reported that all the connections fit properly without the application of force.The coil was successfully removed from the patient and was replaced with another micrusframe 18 coil of the same size and from the same lot number.The detachment control box was powered off and back on again before another pre-deployment electrical check was performed without any issue.The replacement coil was successfully used to complete the procedure.There was no report of any patient injury or complication due to the reported event.The event did not result in a clinically significant delay in the procedure.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: MICRUSFRAME18 8MM X 30CM
• 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: 8936509
• Report Number: 3008114965-2019-01138
• Device Sequence Number: 16250893
• Product Code: KRD
• UDI-Device Identifier: 10886704078210
• UDI-Public: 10886704078210
• 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): 08/08/2019

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: 12/31/2021
• Device Catalogue Number: MFR180830
• Device Lot Number: L14779
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/08/2019
• Supplement Date Received by Manufacturer: 09/09/2019
• Initial Report FDA Received Date: 08/27/2019
• Supplement Report FDA Received Date: 09/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1