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

Catalog Number	400SMTHXSFT0408
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.This report is associated with mfr report number: 3005168196-2019-01954.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the basilar artery using penumbra smart coils (smart coils) and a penumbra smart coil handle (handle).During the procedure, the physician advanced a smart coil in the target vessel using a non-penumbra microcatheter and attempted to detach the smart coil using the handle.After multiple attempts, the smart coil failed to detach although it was reported that the detachment marker was separated into two parts; therefore, the smart coil and handle were removed.The procedure was completed using other smart coils, another handle, and the same microcatheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the pet lock was separated on the proximal end of the pusher assembly.Bends and kinks were present throughout the pusher assembly.The braided shaft was exposed.The pull wire was within the pusher assembly distal detachment tip (ddt) alignment feature.The embolization coil was intact with the pusher assembly ddt.The embolization coil was returned undamaged but was inadvertently kinked by the penumbra investigator during handling.Conclusions: evaluation of the returned smart coil confirmed that the embolization coil would not detach from its pusher assembly.During functional testing, a demonstration handle was connected to the proximal end of the smart coil and was actuated.The embolization coil remained intact with the pusher assembly ddt.Further evaluation of the smart coil revealed the braided shaft was exposed.The root cause of this damage could not be determined.However, this damage likely contributed to the inability to detach the embolization coil during the procedure and functional testing.Additional investigation revealed pusher assembly kinks.These damages were likely incidental to the retorted complaint.Penumbra coils are inspected during in-process inspection and during quality inspection after manufacturing.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 9208865
• Report Number: 3005168196-2019-01953
• Device Sequence Number: 18944743
• Product Code: HCG
• UDI-Device Identifier: 00814548015828
• UDI-Public: 00814548015828
• 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,Followup
• Report Date (Section B): 09/20/2019
• 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: 07/01/2023
• Device Catalogue Number: 400SMTHXSFT0408
• Device Lot Number: F84414
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 09/20/2019
• Supplement Date Received by Manufacturer: 10/25/2019
• Initial Report FDA Received Date: 10/18/2019
• Supplement Report FDA Received Date: 11/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Date Report Sent to FDA: 01/01/2005