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

Model Number	400SMTHXSFT2H04
Medical Device Problem Codes	Appropriate Device Problem Term/Code Not Available (3191); Physical Resistance/Sticking (4012)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/28/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10877379
• Report Number: 3005168196-2020-02055
• Device Sequence Number: 19662033
• Product Code: HCG
• UDI-Device Identifier: 00814548015750
• UDI-Public: 00814548015750
• Combination Product (Y/N): Y
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K160832
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/28/2020
• Report Date (Section F): 01/01/2005

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
• Operator of Device: 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 to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 10/28/2020
• Supplement Date Received by Manufacturer: 06/02/2021
• Initial Report FDA Received Date: 11/20/2020
• Supplement Report FDA Received Date: 06/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 53 YR
• Date Report Sent to FDA: 01/01/2005