MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL CASHMERE 14 - CERECYTE MICROCOIL; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	CRC14022530
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/10/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Mfg name - codman & shurtleff, inc.Dba depuy synthes products, inc.Three attempts to obtain additional information and product return were unsuccessful.It was reported that the device would be returned for analysis; however, it has not yet been returned additional information will be submitted within 30 days of receipt.
Event or Problem Description
As reported by a healthcare professional, during the procedure, the cashmere coil (crc14022530/m10553) could not be detached.They used another one to complete the procedure.There was no report of patient injury.It was reported that the device would be returned for analysis.
Additional Manufacturer Narrative
Conclusion: as reported by a healthcare professional, during the procedure, the cashmere coil (crc14022530/m10553) could not be detached.They used another one to complete the procedure.There was no report of patient injury.It was reported that the device would be returned for analysis.It was reported that the device would be returned for analysis; however, the device was not returned, and after several attempts to obtain additional information, no information could be obtained.The cashmere product 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.The failure to detach the coil could not be confirmed without product return for analysis.The root cause of the event could not be determined.There is no current safety signal identified related to the reported event based on review of complaint history for the device.Since there was no evidence to suggest the event was related to a manufacturing issue, no corrective actions will be taken at this time.

• Brand Name: CASHMERE 14 - CERECYTE MICROCOIL
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; rue girardet 29; le locle jura ; SZ
• MDR Report Key: 6947134
• Report Number: 1226348-2017-00171
• Device Sequence Number: 13611403
• Product Code: HCG
• UDI-Device Identifier: 00878528004400
• UDI-Public: (01)00878528004400(17)170620(10)M10553
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K072173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/20/2017

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: 06/20/2017
• Device Catalogue Number: CRC14022530
• Device Lot Number: M10553
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/20/2017
• Supplement Date Received by Manufacturer: 11/16/2017
• Initial Report FDA Received Date: 10/13/2017
• Supplement Report FDA Received Date: 11/20/2017
• Patient Sequence Number: 1