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

Model Number	RBYPCLP30
Medical Device Problem Codes	Failure to Advance (2524); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/21/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of the returned packing coil lp revealed that the embolization coil was advanced out of its introducer sheath and had offset coil winds along its length.The reported inability to advance the coil from its initial position after re-sheathing could not be confirmed.If the packing coil lp is forcefully advanced against resistance, damage such as offset coil winds may occur.Further evaluation revealed a broken pet 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 re-sheathed from its returned position.While attempting to advance the packing coil lp, resistance was encountered due to the offset coil winds, and the device could not be advanced at all.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 in the colic artery using packing coil lps and a non-penumbra microcatheter.During the procedure, the physician advanced a packing coil lp through the microcatheter and into the target vessel.However, the physician was not satisfied with the placement of the packing coil lp; therefore, the physician retracted the packing coil lp and repositioned the microcatheter.Subsequently, while attempting to re-advance the same packing coil lp, the physician noticed the packing coil lp was stuck and would not advance at all past its initial position within its introducer sheath.Therefore, the packing coil lp was removed.The procedure was completed using another packing coil lp 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: 12178269
• Report Number: 3005168196-2021-01560
• Device Sequence Number: 3357121
• Product Code: HCG
• UDI-Device Identifier: 00815948021938
• UDI-Public: 00815948021938
• Combination Product (Y/N): Y
• Initial Reporter State: OR
• 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): 07/15/2021
• 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: 03/07/2026
• Device Model Number: RBYPCLP30
• Device Catalogue Number: RBYPCLP30
• Device Lot Number: F104421
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2021
• 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: 06/22/2021
• Initial Report FDA Received Date: 07/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 26 YR
• Date Report Sent to FDA: 01/01/2005