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

Model Number	RBYPCLP15
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of the returned packing coil lp revealed that the pusher assembly was kinked and fractured.This type of damage typically occurs due to manipulation against resistance.Based on the reported complaint, the packing coil lp would not advance past the friction lock.This may have contributed to the resistance during the attempt to advance pusher assembly through its introducer sheath.Further evaluation revealed that the embolization coil was detached and had offset coil winds, and the introducer sheath was off the pusher assembly.This damage was incidental to the reported complaint.The detached embolization coil likely occurred due to the fractured pusher assembly.The offset coil winds likely occurred during packaging of the device for return.The root cause of the introducer sheath being off the pusher assembly could not be determined.Due to the returned damage, the root cause of the reported complaint could not be determined.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.
Event or Problem Description
The patient was undergoing a coil embolization procedure to treat a type ii endoleak using packing coil lps, penumbra smart coils, a non-penumbra coil and a non-penumbra microcatheter.During the procedure, the physician placed several smart coils, packing coil lps and non-penumbra coils in the target location using the microcatheter.While attempting to place another packing coil lp in the target vessel, the hospital technician was unable to advance the packing coil lp past the friction lock.The physician also tried advancing the same packing coil lp; however, it would not advance at all past its initial position.Therefore, it was removed.The procedure was completed using a new packing coil lp, additional lp coils and non-penumbra coils and the same microcatheter.There was no report of an adverse effect to the patient.

• Brand Name: PACKING COIL LP
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 12153752
• Report Number: 3005168196-2021-01517
• Device Sequence Number: 11953321
• Product Code: HCG
• UDI-Device Identifier: 00815948021921
• UDI-Public: 00815948021921
• Combination Product (Y/N): Y
• Initial Reporter State: NJ
• 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
• Report Date (Section B): 07/12/2021
• 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: 03/22/2026
• Device Model Number: RBYPCLP15
• Device Catalogue Number: RBYPCLP15
• Device Lot Number: F104797
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2021
• 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: 06/15/2021
• Initial Report FDA Received Date: 07/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 83 YR
• Date Report Sent to FDA: 01/01/2005