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

Catalog Number	400SMTSTD0620
Medical Device Problem Codes	Fracture (1260); Retraction Problem (1536); Physical Resistance (2578)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/24/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the penumbra smart coil (smart coil) detachment tip was fractured where the polymer section of the pusher assembly meets the distal detachment tip (ddt).The pusher assembly was kinked in multiple locations along its length.Conclusions: evaluation of the returned smart coil pusher assembly revealed that the ddt was fractured from the polymer section of the pusher assembly.If the smart coil pusher assembly is retracted through an overtightened rhv, damage such as this may occur.This is further supported due to the ddt being found inside the rhv indicating that it was successfully retracted out of the patient.Further evaluation revealed that the pusher assembly was kinked in multiple locations along its length.This damage was likely incidental and occurred after the procedure based on the reported successful result of the case up to the final retraction of the pusher.The non-penumbra microcatheter and intraluminal support stent device 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 stent assisted coil embolization procedure in the left vertebral artery using penumbra smart coils (smart coils).During the procedure, the physician placed an intraluminal support stent device in the neck portion of the aneurysm.Next, the physician deployed a smart coil into the target vessel as the first framing coil by the jailing technique using a non-penumbra microcatheter.However, after detaching the smart coil, the physician attempted to retract the smart coil pusher assembly from the microcatheter but encountered resistance.Subsequently, about three centimeters of the tip of the pusher assembly became fractured inside the non-penumbra rotating hemostasis valve (rhv).Therefore, the rhv was removed and the procedure was completed using a new rhv and additional 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: 6811922
• Report Number: 3005168196-2017-01417
• Device Sequence Number: 2066632
• Product Code: HCG
• UDI-Device Identifier: 00814548014678
• UDI-Public: 00814548014678
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K160832
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/27/2017

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: 07/11/2021
• Device Catalogue Number: 400SMTSTD0620
• Device Lot Number: F70559
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/27/2017
• Initial Report FDA Received Date: 08/22/2017
• 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
• Patient Weight: 77