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

Model Number 400SMTXSFT4H12

Device Problems Failure to Advance (2524); Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/05/2021

Event Type  malfunction  

Event Description

The patient was undergoing a coil embolization procedure in the posterior cerebral arteries (pca) using penumbra smart coils (smart coil) and a non-penumbra microcatheter.During the procedure, the smart coil would not advance from the starting position within its introducer sheath, and subsequently the physician kinked the pusher assembly of the smart coil.Therefore, the smart coil was removed.The procedure was completed using a new smart coil.There was no report of an adverse effect to the patient.

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.

• 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: 12960519
• MDR Text Key: 281923308
• Report Number: 3005168196-2021-02771
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548017204
• UDI-Public: 00814548017204
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/01/2005,12/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 400SMTXSFT4H12
• Device Catalogue Number: 400SMTXSFT4H12
• Device Lot Number: F101274
• 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: 11/10/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/20/2020
• 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