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

Catalog Number	CRC14040630
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/25/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Udi: (b)(4).Conclusion: the device was not available for analysis.A review of the manufacturing documentation associated with this lot presented no issues during the manufacturing or inspection process that can be related to the reported complaint.The failure to detach issue could not be confirmed without product return for analysis.The root cause could not be determined; however, procedural factors may have contributed to the event.Since there was no evidence to suggest the event was not related to a manufacturing issue, no corrective actions will be taken at this time.This is an initial/final mdr report.
Event or Problem Description
As reported by a healthcare professional, during abdominal viscera aneurysm at the renal artery, a cashmere coil (crc14040630/c36048) could not be detached.The cashmere was used for the first coil during the procedure; however, it could not be deployed when handling it for deployment.Therefore, the coil was replaced with another coil (same size).The coil also could not be deployed, therefore the control box (catalog/lot unknown) was replaced with another one and the coil could be deployed.The procedure was successfully completed without further issues or delayed.There was also no patient injury / complication reported.The complaint product was new and stored per labeling instructions.The procedure was conducted in accordance with the ifu and the constant flush had been maintained at all time.No visible defect/damage was noted on the products prior to or after the event.No unintended detachment was observed in the vessel or in the microcatheter.The product was not available as it had been discarded by the customer.No further information was available.

• Brand Name: CASHMERE 14 - CERECYTE MICROCOIL
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel ; SZ
• MDR Report Key: 6177207
• Report Number: 2954740-2016-00314
• Device Sequence Number: 19064871
• Product Code: HCG
• UDI-Device Identifier: 00878528004462
• UDI-Public: (01)00878528004462(17)200531(10)C36048
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Report Date (Section B): 11/29/2016

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: 05/31/2020
• Device Catalogue Number: CRC14040630
• Device Lot Number: C36048
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/29/2016
• Initial Report FDA Received Date: 12/15/2016
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DETACHMENT CONTROL BOX