MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL PRESIDIO 18 - CERECYTE MICROCOIL; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	PC418113730
Medical Device Problem Codes	Difficult or Delayed Positioning (1157); Stretched (1601)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/09/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is one of one initial/final mdr being submitted for this complaint with associated mfr# 2954740-2016-00210.(b)(4).Concomitant medical products: micro catheter (headway, terumo), y connector (meg okay, goodman) and enpower.The presidio will not be returned; therefore the root cause of the coil unraveling in the rhv 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
As reported by a healthcare professional, during coil embolization of an aneurysm at the renal artery a presidio 18 coil (pc418113730/ c28745) unraveled.Patient was a (b)(6) female whose vessels were heavily torturous and mildly calcified.It was reported that the presidio coil unraveled when the wire was handled around y connector, the coil also partially deployed out of the distal end of the microcatheter (competitor's device).The coil was safely removed from the patient along with the microcatheter and replaced with another coil (same size, another product).The procedure was completed without further issues or delay.There were no patient injuries or complications reported.The complaint product was new and stored per labeling instructions.The procedure was conducted in accordance with the ifu and a constant flush was maintained at all times.No visible defect or damage was noted on the products prior to and after the event.No unintended detachment was observed in the vessel or in the microcatheter.The product is not available for the investigation.No further information is available.

• Brand Name: PRESIDIO 18 - CERECYTE MICROCOIL
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel ; SZ
• MDR Report Key: 5962950
• Report Number: 2954740-2016-00210
• Device Sequence Number: 19054915
• Product Code: HCG
• UDI-Device Identifier: 00878528003236
• UDI-Public: (01)00878528003236(17)190731(10)C28745
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K082739
• 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): 09/09/2016

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: 07/31/2019
• Device Catalogue Number: PC418113730
• Device Lot Number: C28745
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2016
• Initial Report FDA Received Date: 09/20/2016
• Patient Sequence Number: 1
• Patient Age: 70 YR