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

Catalog Number	400SMTSTD1045
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/09/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Results: the smart pe fibers were fractured, and the coil was detached from its pusher assembly.Conclusions: evaluation of the returned smart coil revealed that the coil was detached, and the pe fibers were fractured.The pusher assembly was not returned; therefore, the root cause of the unintentional detachment could not be determined.If the device is forcefully retracted against resistance, the embolization coil may detach.It was reported that multiple snares were advanced up to break the coil.This may have been what caused the pe fibers to fracture.The snaring of the coil may have contributed to additional embolization coil damage.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.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the anterior communicating artery (acom) using penumbra smart coils (smart coils).During the procedure, the physician attempted to advance the first coil, a smart coil, into the target vessel using a non-penumbra microcatheter that was jailed with a stent and a benchmark 6f 071 delivery catheter (benchmark).However, after two thirds of the smart coil was advanced into the aneurysm, the catheter began to kick back out of the aneurysm.It was reported that further attempts to advance the microcatheter and smart coil were unsuccessful.When attempting to retract both the smart coil and catheter, the physician felt resistance and the smart coil unintentionally detached from the pusher assembly.The physician then advanced multiple snare devices through the benchmark to break the smart coil and was able to retract the benchmark with part of the smart coil and the snares out of the patient.The physician stented the other part of the smart coil to the cervical portion of the carotid artery, and the procedure was completed using a new benchmark, new microcatheter, and new coils.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: 8144598
• Report Number: 3005168196-2018-02386
• Device Sequence Number: 1910808
• Product Code: HCG
• UDI-Device Identifier: 00814548014401
• UDI-Public: 00814548014401
• Combination Product (Y/N): Y
• Initial Reporter State: CO
• 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): 11/09/2018
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/17/2023
• Device Catalogue Number: 400SMTSTD1045
• Device Lot Number: F84127
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2018
• 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: 11/09/2018
• Initial Report FDA Received Date: 12/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR
• Date Report Sent to FDA: 01/01/2005