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

Model Number 400SMTHXSFT0306

Device Problem Difficult to Advance (2920)

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

Event Date 10/13/2021

Event Type  malfunction  

Event Description

The patient was undergoing a coil embolization procedure in the anterior communicating artery (acom) using penumbra smart coils (smart coils) and a non-penumbra microcatheter.During the procedure, a smart coil was reported to be stiff and could not be fully inserted into the aneurysm.It was also reported that the smart coil kicked the microcatheter out of the target location.After several attempts to implant the same smart coil, the same issue continued to occur.Therefore, the smart coil was removed.Next, the same issue occurred with the next two smart coils.Therefore, these smart coils were also removed.The procedure was completed using non-penumbra coils and the same microcatheter.There was no report of an adverse effect to the patient.

Manufacturer Narrative

This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.This report is associated with mfr report numbers: 3005168196-2021-02505, 3005168196-2021-02507.

Manufacturer Narrative

Evaluation of the returned smart coil revealed offset coil winds.If the device is forcefully advanced against resistance, damage such as offset coil winds may occur.This damage likely contributed to the embolization coil being stiff during the procedure.The introducer sheath was not returned for evaluation; therefore, during the functional test, the device was sheathed with a demonstration introducer sheath during functional testing, then the smart coil could not advance out of the introducer sheath due to the offset coil winds.Evaluation of the returned smart coil revealed offset coil winds.If the device is forcefully advanced against resistance, damage such as offset coil winds may occur.This damage likely contributed to the embolization coil being stiff during the procedure.During functional testing, the device was able to advance through its introducer sheath and a demonstration microcatheter without issue.Evaluation of the returned smart coil revealed that the pusher assembly mid-joint was retracted proximal to the introducer sheath friction lock.If this occurs, resistance will likely be experienced during advancement.During functional testing, the pusher assembly mid-joint was advanced through the introducer sheath friction lock with resistance.Then the device was able to advance through its introducer sheath without issue.Penumbra coils are visually inspected during in-process inspection and during quality inspection after manufacturing.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 numbers: 1.3005168196-2021-02505.2.3005168196-2021-02507.

• 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: 12771465
• MDR Text Key: 283312874
• Report Number: 3005168196-2021-02506
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548015781
• UDI-Public: 00814548015781
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: K160832
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,12/29/2021

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: Health Professional
• Device Model Number: 400SMTHXSFT0306
• Device Catalogue Number: 400SMTHXSFT0306
• Device Lot Number: F104916
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2021
• 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
• Initial Date Manufacturer Received: 10/15/2021
• Initial Date FDA Received: 11/08/2021
• Supplement Dates Manufacturer Received: 12/17/2021
• Supplement Dates FDA Received: 12/29/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/26/2021
• 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