MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SMART COIL; HCG, KRD

Catalog Number 400SMTXSFT0306

Device Problems Positioning Failure (1158); Difficult To Position (1467)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/30/2016

Event Type  malfunction  

Manufacturer Narrative

The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.This report is associated with mfr report number: 3005168196-2016-01245.The hospital disposed of the device.

Event Description

The patient was undergoing a coil embolization procedure using penumbra smart coils (smart coils).During the procedure, the physician advanced a smart coil (lot #f65212) out of the other manufacturer's microcatheter without any resistance and attempted to deploy the coil into the aneurysm.However, the first loop of the coil kept popping out of the aneurysm and the physician was unable to properly position the coil.Therefore, the smart coil was re-sheathed and removed without an issue.Next, the physician advanced a new smart coil (lot #f66570) through the same microcatheter without resistance and attempted to deploy this coil into the aneurysm.However, the microcatheter kicked out once the coil was being pushed into the aneurysm.Therefore, this smart coil was also resheathed and removed without an issue.The procedure was then completed using another manufacturer's coils and the same microcatheter.It should be noted that the physician maintained a continuous flush and used a rotating hemostasis valve (rhv) throughout the procedure.There was no report of an adverse effect to the patient.

• Brand Name: PENUMBRA SMART COIL
• Type of Device: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: kathleen kidd ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 5906926
• MDR Text Key: 53102588
• Report Number: 3005168196-2016-01244
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548015354
• UDI-Public: 00814548015354
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160832
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/31/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 11/16/2020
• Device Catalogue Number: 400SMTXSFT0306
• Device Lot Number: F66570
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/31/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/18/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 72 YR