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

Catalog Number	CRC14051230
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/13/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is initial/final mdr report with associated mfr# 2954740-2017-00222 and 3008264254-2017-00112.(b)(4).Concomitant medical products: micro catheter (prowler select lpes), a y connector (okay, goodman), and an enpower cable.Reporter ph# (b)(6).Based on the information, the reported event of resistance experienced and coil introducer damage could not be confirmed.The cashmere coil was not returned for analysis; however, 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.Therefore, no corrective actions will be taken at this time.There is no current safety signal identified related to the reported event based on review of complaint history for the device.
Event or Problem Description
As reported by a healthcare professional during the procedure, resistance was experienced when a presidio10 coil (pc410073030/c23504) and a cashmere coil (crc14051230/s11722) were advanced through a prowler catheter (606s155fx/17574497).Introducer sheath of both the presidio10 coil and the cashmere coil were also damaged.The procedure was pre-endovascular aneurysm repair coil embolization at branch(es) of the left internal iliac artery.The patient was a (b)(6) male.The patient¿s vessel was heavily torturous and heavily calcified.The presidio10 coil was delivered however resistance was experienced with the prowler catheter.Reportedly the diameter of the prowler select lpes was small.The introducer sheath of the presidio 10 coil got damaged during framing.Therefore, it was replaced with a cashmere coil (crc14051230/s11722), but the sheath got damaged as well.Therefore, the micro catheter was replaced with other microcatheter (select plus), and a new coil was delivered (presidio8*30).The procedure was completed using micrus coil(s).Excessive force was not used when handling the complaint coils and no difficulty was experienced when handling the two complaint coils.The procedure was successfully completed without further issues or delay.There was also no patient injury / complication reported.The complaint products were 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 and after the event.No unintended detachment was observed in the vessel or in the micro catheter.The products are not available for the investigation.No further information is 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: 6771629
• Report Number: 2954740-2017-00222
• Device Sequence Number: 13637931
• Product Code: HCG
• UDI-Device Identifier: 00878528004523
• UDI-Public: (01)00878528004523(17)210831(10)S11722
• 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): 07/13/2017

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: 08/31/2021
• Device Catalogue Number: CRC14051230
• Device Lot Number: S11722
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/13/2017
• Initial Report FDA Received Date: 08/07/2017
• Patient Sequence Number: 1