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

Model Number	400SMTSFT0410
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/21/2020
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.This report is associated with mfr report numbers: 3005168196-2020-01214, 3005168196-2020-01216, 3005168196-2020-01217, 3005168196-2020-01218.
Event or Problem Description
The patient was undergoing a coil embolization procedure to treat a carotid cavernous fistula (ccf) using penumbra smart coils, a penumbra smart coil detachment handles (handles), non-penumbra coils and a non-penumbra microcatheter.During the procedure, the physician successfully deployed and detached five smart coils into the target location using the handle.The physician then advanced another smart coil into the target location using the microcatheter and attempted to detach it using the handle; however, the smart coil failed to detach.The physician attempted to pull the back end of the detachment zone; however, the smart coil failed to detach.The physician also attempted to break the stainless steel hypotube and subsequently, the hypotube snapped and there was no inner nitinol wire to pull on.Therefore, the smart coil was removed.Then, the physician advanced another smart coil into the target location using the microcatheter and attempted to detach it using the handle; however, the smart coil failed to detach.The physician then attempted to use a new handle to detach the smart coil; however, the smart coil failed to detach.Therefore, the smart coil was removed.Next, the physician placed non-penumbra coils into the target vessel using the microcatheter.The physician then advanced another smart coil into the target location using the microcatheter and attempted to detach it using the handle; however, the smart coil failed to detach.The physician also attempted to break the stainless steel hypotube and subsequently, the hypotube snapped and there was no inner nitinol wire to pull on.Therefore, the smart coil was removed.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10411312
• Report Number: 3005168196-2020-01215
• Device Sequence Number: 2476651
• Product Code: HCG
• UDI-Device Identifier: 00814548015095
• UDI-Public: 00814548015095
• Combination Product (Y/N): Y
• Initial Reporter Country: CA
• PMA/510(K) Number: K160832
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/21/2020
• 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: 02/24/2025
• Device Model Number: 400SMTSFT0410
• Device Catalogue Number: 400SMTSFT0410
• Device Lot Number: F96530
• 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: 07/21/2020
• Initial Report FDA Received Date: 08/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Date Report Sent to FDA: 01/01/2005