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

Catalog Number	400SMTHXSFT0101
Medical Device Problem Codes	Detachment Of Device Component (1104); Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/07/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the embolization coil was detached from the pusher assembly and had offset coil winds and gaps, and the proximal constraint sphere was intact.Conclusions: evaluation of the returned device revealed the embolization coil was detached and the proximal constraint sphere was intact.Since the penumbra smart coil (smart coil) pusher assembly was not returned for evaluation, the root cause of the reported unintentional detachment could not be determined.Further evaluation revealed the embolization coil had offset coil winds and gaps.This damage may have occurred due to forceful manipulation of the smart coil within tortuous anatomy.The smart coil pusher assembly, non-penumbra microcatheter, and benchmark mentioned in the complaint were not returned for evaluation.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).It was noted that the patient''s anatomy was tortuous.During the procedure, the physician placed a benchmark 6f 071 delivery catheter (benchmark) then advanced a non-penumbra microcatheter through the benchmark.While attempting to advance a smart coil into the target vessel using the microcatheter, the physician realized that the smart coil would not fit into the vessel and decided to remove it; however, upon retraction the smart coil unintentionally detached.Therefore, the physician removed the microcatheter and flushed it.The physician then noticed that the detached coil was not in the microcatheter.Therefore, the physician removed the benchmark and flushed the detached coil out.The procedure was completed by placing a stent device.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: 7313903
• Report Number: 3005168196-2018-00483
• Device Sequence Number: 2300472
• Product Code: HCG
• UDI-Device Identifier: 00814548015590
• UDI-Public: 00814548015590
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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): 02/07/2018

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: Physician
• Device Expiration Date: 11/17/2021
• Device Catalogue Number: 400SMTHXSFT0101
• Device Lot Number: F72147
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/07/2018
• Initial Report FDA Received Date: 03/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 35 YR