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

Catalog Number	CRC14030330
Medical Device Problem Code	Stretched (1601)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/12/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).It was reported that the device would be returned for analysis; however, the device has not yet been returned.Additional information will be submitted within 30 days of receipt.
Event or Problem Description
During the aneurysm embolization procedure, the cashmere 14 coil (crc14030330/c26898) stretched.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
It was reported that the device would be returned for analysis; however, the device has not yet been returned.If the device is returned at a later date, a supplemental mdr will be submitted.During the aneurysm embolization procedure, the cashmere 14 coil (crc14030330/c26898) stretched.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; however, the device was not returned and no additional 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 coil stretching could not be confirmed without product return for analysis.The root cause of the event could not be determined; however, procedural and handling factors may have contributed to the event.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 events was related to a manufacturing issues, no corrective actions will be taken at this time.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).[conclusion]: the healthcare professional reported that during the coil embolization procedure of an aneurysm, the cashmere 14 cerecyte coil 3mm x 3cm (crc14030330 / c26898) became stretched.Another coil was used to complete the procedure.There was no report of patient injury.Investigation summary: the device was returned with its inner pouch.Labeling on the inner pouch matches the product documented in the complaint.The embolic coil is fully advanced out of the introducer.The device is fully unsheathed.The device positioning unit (dpu) is fully advanced through the introducer.There is a severe kink in the dpu core wire at the strain relief.There are bends in the dpu core wire approximately 37 cm, 101 cm, and 156 cm from the proximal end.The ball tip of the embolic coil is missing.The embolic coil is kinked.The articulating joint is compressed longitudinally.The resistance heating (rh) coil has not heated.There is a slight amount of plastic remodeling damage to the v-notch of the resheathing tool.The embolic coil was retracted into the green introducer.In moving the device for dimensional analysis, the embolic coil was inadvertently pulled into the resheathing tool, where it stretched.The stretching damage was not present prior to moving for dimensional analysis.The length of the embolic coil was measured with ruler 70007-02ex.The embolic coil is approximately 3.5 cm long, indicating that the full length of the embolic coil is present, even though the ball tip is missing.A review of manufacturing documentation associated with this lot (c26898) 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.Investigation conclusion: the complaint that the embolic coil was stretched is not confirmed.While the coil stretched during handling in the lab, it was not stretched as returned.However, the embolic coil is kinked and the ball tip is missing.The exact circumstances surrounding the reported event are unknown, but damage to the embolic coil and bends in the dpu core wire suggest that the device was subject to the application of excessive force.The event description documents that damage was observed during use.Since the embolic coil was advanced out of the introducer as returned, it is also possible that some of the observed damage occurred after the reported event, such as during storage and/or return.Additionally, 100% of devices are inspected for condition of the embolic coil during final assembly per mps-prp0246 rev.9.Thus, it is very unlikely that the device left the manufacturing facility with the observed damage to the embolic coil.Device history lot = > a review of manufacturing documentation associated with this lot (c26898) 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.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: 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: 6885938
• Report Number: 2954740-2017-00272
• Device Sequence Number: 496426
• Product Code: HCG
• UDI-Device Identifier: 00878528004417
• UDI-Public: (01)00878528004417(17)190523(10)C26898
• 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,Followup
• Report Date (Section B): 08/30/2017

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: 05/23/2019
• Device Catalogue Number: CRC14030330
• Device Lot Number: C26898
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2018
• Initial Date Received by Manufacturer: 08/30/2017
• Supplement Date Received by Manufacturer: 10/25/2017; 06/28/2018
• Initial Report FDA Received Date: 09/22/2017
• Supplement Report FDA Received Date: 10/26/2017; 07/19/2018
• Patient Sequence Number: 1