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

Catalog Number	400SMTHXSFT0101
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/23/2019
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 numbers: 3005168196-2019-01212, 3005168196-2019-01213.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the right posterior communicating artery (pcom) using penumbra smart coils (smart coils).During the procedure, while attempting to advance a smart coil into a non-penumbra microcatheter, the physician experienced extreme resistance and the smart coil would not advance out of its introducer sheath; therefore, it was removed.The physician attempted to advance a new smart coil, but the same issue occurred and, therefore, it was removed.The physician experienced resistance while attempting to advance a third smart coil; however, the physician continued to push very hard and reported that he felt it ¿popped¿ forward and the smart coil was successfully placed in the target vessel and completed the procedure.There was no 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: 8720416
• Report Number: 3005168196-2019-01214
• Device Sequence Number: 1821379
• Product Code: HCG
• UDI-Device Identifier: 00814548015590
• UDI-Public: 00814548015590
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• 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): 05/23/2019
• 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: 12/12/2022
• Device Catalogue Number: 400SMTHXSFT0101
• Device Lot Number: F80995
• 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: 05/23/2019
• Initial Report FDA Received Date: 06/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Weight: 59
• Date Report Sent to FDA: 01/01/2005