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

Model Number	RBYPCLP30
Medical Device Problem Codes	Failure to Fold (1255); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/03/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the prostate artery using packing coil lps and a non-penumbra microcatheter.During the procedure, the packing coil lp would not take its intended shape within the target vessel.The packing coil lp was straight and was not coiling.It was reported that the physician experienced resistance while advancing the packing coil lp into the target vessel.Therefore, the packing coil lp was removed.The procedure was completed using a new lp coil and the same microcatheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned packing coil lp could not confirm that the embolization coil did not take its intended shape.Further evaluation revealed kink in the pusher assembly, and the pusher assembly mid-joint was retracted proximal to the introducer sheath friction lock.This damage was incidental to the reported complaint, and the root cause could not be determined.During the functional test, the packaging coil lp was advanced out of its introducer sheath with resistance due to the pusher assembly mid-joint being proximal to the introducer sheath friction lock, and a shape was present on the embolization coil.Penumbra coils are visually 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.

• Brand Name: PACKING COIL LP
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 12411382
• Report Number: 3005168196-2021-01888
• Device Sequence Number: 5304501
• Product Code: HCG
• UDI-Device Identifier: 00815948021938
• UDI-Public: 00815948021938
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K192955
• 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,Followup
• Report Date (Section B): 09/17/2021
• 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: 02/04/2026
• Device Model Number: RBYPCLP30
• Device Catalogue Number: RBYPCLP30
• Device Lot Number: C27052
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 08/03/2021
• Supplement Date Received by Manufacturer: 09/02/2021
• Initial Report FDA Received Date: 09/01/2021
• Supplement Report FDA Received Date: 09/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Date Report Sent to FDA: 01/01/2005