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

Model Number 400SMTHXSFT2H04

Device Problems Appropriate Term/Code Not Available (3191); Physical Resistance/Sticking (4012)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/28/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Appropriate term/code no available to describe the issue of gap in the pusher assembly of the smart coil within the introducer sheath.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: 3005168196-2020-02053, 3005168196-2020-02054.

Event Description

The patient was undergoing a coil embolization procedure in the bifurcation of the anterior cerebral artery (aca) and anterior communicating artery (acom) using penumbra smart coils (smart coils) and non-penumbra microcatheter.During the procedure, both smart coils would not advance from the starting position within the introducer sheath.Therefore, both smart coils were removed.Next, a new smart coil was advanced into the aneurysm; however, the physician decided to retract the smart coil to reposition the microcatheter.While retracting the smart coil back into the introducer sheath, the physician experienced resistance.Subsequently, the physician retracted the smart coil partially back into the introducer sheath and removed the smart coil.It was also reported that the physician noticed a gap in the pusher assembly of the smart coil within the introducer sheath.The procedure was completed using new smart coils and the same microcatheter.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Please note that the device associated with this complaint was expected to be returned; however, additional information received from the penumbra sales representative indicated that the device was disposed of and is no longer available for return.Therefore, 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 numbers: 1.3005168196-2020-02053, 2.3005168196-2020-02054.H3 other text: placeholder.

• Brand Name: PENUMBRA SMART COIL
• Type of Device: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10877379
• MDR Text Key: 217660701
• Report Number: 3005168196-2020-02055
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548015750
• UDI-Public: 00814548015750
• 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: 01/01/2005,10/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/20/2022
• Device Model Number: 400SMTHXSFT2H04
• Device Catalogue Number: 400SMTHXSFT2H04
• Device Lot Number: F74547
• 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
• Date Manufacturer Received: 06/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 53 YR