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

Catalog Number	SRC14102520
Medical Device Problem Codes	Stretched (1601); Physical Resistance (2578)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/04/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Procode: krd/hcg.Concomitant medical products: sl 10 microcatheter, envoy guide catheter.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 coil stretching and resistance within the microcatheter could not be confirmed without product return for analysis.The root cause of the event could not be determined; however, procedural factors or the microcatheter may have contributed to the event.Since there was no evidence to suggest the event was 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, while repositioning a cashmere coil (src14102520/ c25290) for treatment of an aneurysm off the internal carotid artery, the physician felt that the coil was stretching due to resistance with the microcatheter resulting in loss of target position.The device had appeared normal prior to use.An sl 10 microcatheter was used for the procedure, and an adequate continuous flush had been maintained through the microcatheter at all times.Prior to this coil, other coils had gone through the same microcatheter without resistance; however, coil entanglement did not contribute to the coil stretching.The microcatheter had not been repositioned over the coil while the coil was deployed or partially deployed out of the distal end of the microcatheter.The entire coil was removed still attached to the dpu, and after removal, the microcatheter tip was reintroduced into the aneurysm.There was no need for additional intervention to remove the coil.The event did not restrict blood flow.There was no patient injury or clinically significant delay in the procedure.It was reported that the device was accidentally discarded by the hospital staff.

• Brand Name: CASHMERE 14 - PLATINUM MICROCOIL
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel ; SZ
• MDR Report Key: 6105480
• Report Number: 2954740-2016-00274
• Device Sequence Number: 440992
• Product Code: HCG
• UDI-Device Identifier: 00878528004059
• UDI-Public: (01)00878528004059(17)190225(10)C25290
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K022420
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 11/04/2016

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: 02/25/2019
• Device Catalogue Number: SRC14102520
• Device Lot Number: C25290
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2016
• Initial Report FDA Received Date: 11/16/2016
• Patient Sequence Number: 1