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

Catalog Number 400SMTXSFT0306

Device Problems Failure to Advance (2524); Mechanical Jam (2983)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/24/2017

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: 3005168196-2017-02036.The hospital discarded the device.

Event Description

The patient was undergoing a coil embolization procedure to treat a dural fistula using penumbra smart coils (smart coils).During the procedure, the physician was unable to advance two smart coils into a non-penumbra microcatheter; therefore, they were removed.It was also reported that the distal detachment tip (ddt) seemed to get caught up on the inner hub of the microcatheter.The procedure was completed using other smart coils and the same microcatheter.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Please note that the following sections were incorrectly reported on the initial mfr report and are being corrected on this follow-up #01 mfr report: 3005168196-2017-02037.Lot #/catalog #/expiration date/unique identifier.Device manufacture date.

• Brand Name: PENUMBRA SMART COIL
• Type of Device: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7025586
• MDR Text Key: 92918642
• Report Number: 3005168196-2017-02037
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548015996
• UDI-Public: 00814548015996
• Combination Product (y/n): Y
• PMA/PMN Number: K160832
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,10/24/2017

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
• Device Operator: Physician
• Device Expiration Date: 05/18/2021
• Device Catalogue Number: 400SMTXSFT0306
• Device Lot Number: F69383
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Initial Date Manufacturer Received: 10/24/2017
• Initial Date FDA Received: 11/13/2017
• Supplement Dates Manufacturer Received: 01/14/2005
• Supplement Dates FDA Received: 01/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 56 YR