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

Catalog Number	400SMTSTD1560
Medical Device Problem Codes	Failure to Advance (2524); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/24/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the distal detachment tip was fractured.The embolization coil was detached from the pusher assembly and its proximal constraint sphere was intact on the proximal end of the embolization coil.The pull wire was visible protruding distal from the fractured pusher assembly where the distal detachment tip had sheared off.There was an unknown substance coagulated on two locations of the embolization coil.Conclusions: evaluation of the returned smart coil revealed the embolization coil was detached and the distal detachment tip was sheared off from the pusher assembly.The distal detachment tip shearing from the pusher assembly was likely a result of the forceful retraction against resistance experienced during the procedure.If the distal detachment tip becomes sheared off the pusher assembly, it will result in the pull wire retracting out of the distal detachment tip, detaching the embolization coil.Further evaluation of the embolization coil revealed an unknown substance coagulated on the device in two locations.This substance may have become coagulated post-procedure within the microcatheter during return to penumbra.Evaluation of the returned smart coil revealed kinks on the pusher assembly.This damage is likely a result of forcefully advancing the device against the resistance experienced during the procedure.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.This report is associated with mfr report number: 3005168196-2018-02296.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the external carotid artery (eca) using a penumbra smart coil (smart coil).During the procedure, while attempting to advance a smart coil through a non-penumbra microcatheter, the physician experienced resistance and decided to remove the smart coil.The physician then chose another smart coil and was able to advance it a little farther than the previous smart coil; however, resistance was encountered again and upon removal, the smart coil unintentionally detached inside the microcatheter.Therefore, the physician removed the microcatheter containing the detached coil.The procedure was completed using a new microcatheter and additional coils.There was no report of 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: 8097958
• Report Number: 3005168196-2018-02297
• Device Sequence Number: 16689013
• Product Code: HCG
• UDI-Device Identifier: 00814548014302
• UDI-Public: 00814548014302
• 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): 10/24/2018
• 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: 09/19/2022
• Device Catalogue Number: 400SMTSTD1560
• Device Lot Number: F79632
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2018
• 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: 10/24/2018
• Initial Report FDA Received Date: 11/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Date Report Sent to FDA: 01/01/2005