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

Model Number	400SMTXSFT0204
Medical Device Problem Codes	Failure to Advance (2524); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/11/2020
Type of Reportable Event	Malfunction
Additional 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.This report is associated with mfr report number: 3005168196-2020-01397.
Event or Problem Description
The patient was undergoing a coil embolization procedure in internal carotid artery (ica) using penumbra smart coils (smart coils), penumbra coils 400 (pc400s), a px slim delivery microcatheter (px slim), and non-penumbra microcatheter.It was reported that the patient was in poor condition prior to the procedure; the patient had a bleed and an arteriovenous (av) fistula.During the procedure, a smart coil would not advance in the introducer sheath and was stuck at the friction lock.Subsequently, the smart coil was removed, and the physician implanted another smart coil in the target vessel using the microcatheter.Next, while advancing a pc400 through the px slim, the pc400 unintentionally detached in the px slim.Therefore, the px slim containing the detached pc400 was removed.The procedure was completed using another pc400 and the same px slim.There was no report of an adverse effect to the patient.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10497408
• Report Number: 3005168196-2020-01396
• Device Sequence Number: 2687549
• Product Code: HCG
• UDI-Device Identifier: 00814548015286
• UDI-Public: 00814548015286
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• 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
• Report Date (Section B): 08/12/2020
• 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: 01/25/2025
• Device Model Number: 400SMTXSFT0204
• Device Catalogue Number: 400SMTXSFT0204
• Device Lot Number: F95789
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2020
• Initial Report FDA Received Date: 09/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005