MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL PRESIDIO 10 - CERECYTE MICROCOIL; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	PC410041230
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/17/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is two of two initial/final mdr report being submitted with associated mfr number 2954740-2016-00262 and 3008264254-2016-00075.(b)(4).The presidio coil will not be returned; therefore the coil¿s resistance inside the microcatheter cannot be determined.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.Since there was no evidence of a manufacturing issue related to the event, no corrective action will be taken at this time.
Event or Problem Description
It was reported by a contact at the user facility that during a coil embolization of a ruptured aneurysm at the right posterior communicating artery the physician experienced resistance when using three presidio coil ((b)(4)/lot# c18183, c19118 and c20979) and a prowler select plus catheter (606s155fx/17358075).The aneurysm measured 10 mm x 4 mm x 4 mm.A prowler select lp es was selected as the micro catheter.The aneurysm was accessed without incident using a synchro guide wire.The prowler select micro catheter was then tracked over the wire and into the aneurysm without incident.The physician then attempted to insert a presidio microcoil 4 x 11.5 (lot# c18183).Upon introduction into the micro catheter resistance was encountered in the proximal shaft of the catheter and the coil was unable to be pushed distally.The physician then removed the presidio microcoil.The physician then used the synchro guide wire to re-access the aneurysm ensuring that the micro catheter lumen was intact.The physician then re-attempted to introduce the presidio microcoil without success, as the same resistance issue was experienced.The physician then requested that a new presidio 4x11.5 microcoil (lot# c19118) be opened and the first presidio was discarded.The second presidio encountered the same exact problem and was also discarded.The physician then requested a new micro catheter and an sl-10,.0165 id, was chosen.The prowler select mc was discarded.The sl-10 was introduced into the aneurysm without incident.A third presidio 4 x 11.5(lot# c20979) was requested.Upon attempting to insert the third presidio 4 x 11.5, the same resistance issue was encountered.The coil was then removed and discarded.The physician then requested a presidio 5 x 17 (lot unknown).This coil was inserted into the sl-10 and deployed into the aneurysm without incident.Next, the physician introduced a presidio 4 x 11.5 (lot unknown) into the aneurysm and deployed it without incident.The physician then introduced into the aneurysm, and deployed without incident, an ultipaq 3 x 6 (lot unknown) and a deltaplush 3 x 4 (lot unknown) respectively.This was the final aspect of the intervention and the patient was in good condition.The patient was a 40 year old male whose vessels were reported to be of medium tortuosity.There were no damages reported on the complaint products prior to use or upon removal.The procedure was delayed by 20 minutes.It was reported that the complaint products are not available for analysis.

• Brand Name: PRESIDIO 10 - CERECYTE MICROCOIL
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel ; SZ
• MDR Report Key: 6070425
• Report Number: 2954740-2016-00262
• Device Sequence Number: 863314
• Product Code: HCG
• UDI-Device Identifier: 00878528003007
• UDI-Public: (01)00878528003007(17)180619(10)C19118
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K082739
• 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): 10/17/2016

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: 06/19/2018
• Device Catalogue Number: PC410041230
• Device Lot Number: C19118
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/17/2016
• Initial Report FDA Received Date: 11/01/2016
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SYNCHRO GUIDE WIRE
• Patient Age: 40 YR