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

Catalog Number	400SMTSFT0308
Medical Device Problem Codes	Failure to Advance (2524); Difficult or Delayed Separation (4044); Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/18/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Results: there was a slight ovalization on the distal end of the catheter just proximal to the first marker band.The returned guidewire and a 0.016¿ mandrel were unable to be advanced through the distal three cm of the non-penumbra catheter.The catheter was cut where the mandrel met resistance and an unknown substance was found within the lumen of the non-penumbra microcatheter.This substance was able to be forced out of the cut portion of the catheter and is believed to be contrast from the procedure.Conclusions: the smart coil pusher assembly and embolization coil were not returned for evaluation; however, evaluation of the returned non-penumbra catheter revealed an unknown substance blocking the distal tip of the device.This substance is believed to be contrast used during the procedure.This substance may have contributed to the inability detaching the embolization coil.If the substance was within the distal detachment tip (ddt) and on the constraint sphere it may have contributed to the difficulty detaching the embolization coil.Subsequently, it likely hardened and would not allow the non-penumbra guidewire to be advanced through it.Without the return of the smart coil, the root cause of the problem cannot be determined.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: 3005168196-2018-02050.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the right internal carotid artery (ica) using a penumbra smart coil handle (handle) and penumbra smart coils (smart coils).During the procedure, the physician advanced a smart coil in the target vessel using a non-penumbra microcatheter and attempted to detach it using a handle; however, the coil failed to detach.After two failed attempts, the physician manually pulled the smart coil¿s black alignment zone (pet lock) apart; however, the smart coil was still coming back with the pusher assembly when the physician pulled back to remove.It was reported that after pulling approximately one and half centimeters of the smart coil inside the microcatheter, the smart coil unintentionally detached.Therefore, the physician tried to push the smart coil with its pusher assembly but it did not advance past a certain point.The physician then tried to push the smart coil with a wire but the smart coil did not advance past the same point in the microcatheter.Therefore, the physician pulled the catheter back, leaving one and half centimeters of the smart coil tail outside the target vessel.The procedure was completed by holding the tail of the smart coil against the wall of the vessel using 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: 7980376
• Report Number: 3005168196-2018-02049
• Device Sequence Number: 1030002
• Product Code: HCG
• UDI-Device Identifier: 00814548015057
• UDI-Public: 00814548015057
• Combination Product (Y/N): Y
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K160832
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/18/2018
• 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: 12/04/2021
• Device Catalogue Number: 400SMTSFT0308
• Device Lot Number: F73014
• Was Device Available for Evaluation?: No
• 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: 09/18/2018
• Initial Report FDA Received Date: 10/18/2018
• 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: 78 YR
• Date Report Sent to FDA: 01/01/2005