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

Catalog Number 400SMTXSFT0206

Device Problems Mechanical Jam (2983); Physical Resistance/Sticking (4012)

Patient Problem No Patient Involvement (2645)

Event Date 09/28/2018

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.

Event Description

The patient was undergoing a coil embolization procedure in the middle meningeal artery using penumbra smart coils (smart coil).During the procedure, the physician successfully placed two non-penumbra coils using a non-penumbra microcatheter.While attempting to advance a smart coil out of the introducer sheath into the saline, the physician experienced resistance in the middle of the introducer sheath and the coil became stuck.Therefore, it was not used in the procedure.The procedure was completed an angiography.There was no 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: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 8001453
• MDR Text Key: 124974744
• Report Number: 3005168196-2018-02126
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548016030
• UDI-Public: 00814548016030
• Combination Product (y/n): Y
• Reporter Country Code: JA
• PMA/PMN Number: K160832
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/01/2005,10/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/08/2023
• Device Catalogue Number: 400SMTXSFT0206
• Device Lot Number: F82740
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 10/03/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/09/2018
• 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