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

Catalog Number	SRC14102520
Medical Device Problem Codes	Kinked (1339); Physical Resistance (2578)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/10/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Conclusion: the cashmere was not returned 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 inability of the cashmere coil to be advanced through the sl10 microcatheter, the coil kink, and the sheath dislodgement could not be confirmed without product return for analysis.The root cause of the event could not be determined; however, procedural/handling factors 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.This is 1 of 2 mdrs being submitted for this complaint with associated referenced numbers of 2954740-2016-00300 and 2954740-2016-00299.
Event or Problem Description
As reported by a healthcare professional, during coil embolization of an anterior communicating artery aneurysm, a cashmere ((b)(4)) could not be advanced through an sl 10 microcatheter, the distal end of the coil was kinked, and the sheath dislodged during resheathing and a galaxy g2 ((b)(4)) was difficult to advanced and was found to be stretched upon removal and was removed from the patient with the microcatheter.Initially, using an envoy da and sl10 microcatheter, a helipaq 10 x 30 was advanced without issue.The compliant cashmere 10 x 14 would not be advanced into the sl 10 microcatheter and when removed, the distal end was kinked.When attempting to re-sheath the coil, the sheath dislodged (the wire came through the sheath).A syncro 2 wire was introduced to check for a kink in the system, but no kink was found.Next a 9 x 25 galaxy 2 coil was introduced into the microcatheter and the last 8-10 inches was too difficult to advanced further.Upon trying to remove the coil, the coil stretched inside the microcatheter, and both were removed.The procedure was completed with a competitor¿s coil.It was reported that there was a 25 minutes delay to select new coils, and no additional interventions were required to remove the coils from the patient.The same microcatheter was used for both events.It was reported that a continuous flush had been maintained through the microcatheter.There was no premature detachment of either coil.The devices were prepped and used as per the ifu.The events did not result in patient injury, and it was reported that the patient was doing fine.Only the galaxy g2 was returned for analysis.

• 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: 6147322
• Report Number: 2954740-2016-00299
• Device Sequence Number: 16312489
• Product Code: HCG
• UDI-Device Identifier: 00878528004059
• UDI-Public: (01)00878528004059(17)190831(10)C29062
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 11/11/2016

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: 08/31/2019
• Device Catalogue Number: SRC14102520
• Device Lot Number: C29062
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/11/2016
• Initial Report FDA Received Date: 12/06/2016
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SL10 MICROCATHETER
• Patient Age: 50 YR