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

Catalog Number	RBYPODJ60
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2021
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 for a renal artery aneurysm using a pod packing coil (podj) and px slim delivery microcatheter (px slim).During the procedure, the physician experience resistance when advancing a podj into the px slim.Therefore, the podj was removed.The procedure was completed using a new podj and the same px slim.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned pod pc revealed offset coil winds.If the device is forcefully advanced against resistance, damage such as this may occur.Further evaluation revealed that the pod pc was returned un-sheathed and the introducer sheath distal tip was damaged, the pusher assembly was kinked, and the embolization coil had offset coil winds throughout its length.Some of this damage may be incidental to the complaint and may have occurred during packaging the device for return to penumbra.During functional testing, the pod pc was re-sheathed with resistance due to the offset coil winds; subsequently, the pod pc could not advance at all within its introducer sheath due to the offset coil winds.The root cause of the initial resistance during the procedure could not 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.

• Brand Name: POD PACKING COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 11401228
• Report Number: 3005168196-2021-00378
• Device Sequence Number: 17285019
• Product Code: HCG
• UDI-Device Identifier: 00814548016733
• UDI-Public: 00814548016733
• Combination Product (Y/N): Y
• Initial Reporter Country: HK
• PMA/510(K) Number: K141134
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/03/2021
• 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: 05/30/2026
• Device Catalogue Number: RBYPODJ60
• Device Lot Number: F83755
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 02/03/2021
• Supplement Date Received by Manufacturer: 03/02/2021
• Initial Report FDA Received Date: 03/02/2021
• Supplement Report FDA Received Date: 03/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005