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

Catalog Number	PC418155030
Medical Device Problem Codes	Unraveled Material (1664); Physical Resistance (2578)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/11/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Conclusion: the devices were not returned for analysis.A review of the manufacturing documentation associated with these lots presented no issues during the manufacturing or inspection process that can be related to the reported complaint.The resistance between the prowler select plus and the presidio and the unraveling of the presidio coil could not be confirmed without product return for analysis.The root cause of the event could not be determined; however, the resistance during withdrawal may have contributed to the coil unraveling, as the coil may have become anchored within the microcatheter.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, during coil embolization of an aneurysm at the right internal iliac artery, there was difficulty with the prowler select plus ((b)(4)) handling, but finally the microcatheter was placed; however a presidio ((b)(4)) was got stuck in the microcatheter and the physician withdrew the coil in the microcatheter, but the coil unraveled.The coil was replaced with another one.Five coils (presidio/cashmere) were used for the procedure.The procedure was successfully completed without further issues or delay.There was also no patient injury / complication reported or procedure delay.The complaint product was 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 unintended detachment was observed in the vessel or in the microcatheter.The products were not available for investigation.No further information was 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: 6547083
• Report Number: 2954740-2017-00090
• Device Sequence Number: 641031
• Product Code: HCG
• UDI-Device Identifier: 00878528003274
• UDI-Public: (01)00878528003274(17)201231(10)C40200
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K002056
• 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): 04/11/2017

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: 12/31/2020
• Device Catalogue Number: PC418155030
• Device Lot Number: C40200
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2017
• Initial Report FDA Received Date: 05/05/2017
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MICROCATHETER (PROWLER SELECT PLUS)
• Patient Age: 78 YR