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

Catalog Number	RBYPODJ30
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	02/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for return.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 using a pod packing coil (podj) and a non-penumbra microcatheter.During the procedure, the physician placed a podj in the target location using the microcatheter.Afterwards, the physician experienced resistance while attempting to advance the next podj within its introducer sheath.Subsequently, the podj would not advance within its introducer sheath.Therefore, the podj was removed.The procedure was completed using a ruby coil.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned pod pc revealed that the embolization coil was detached from the pusher assembly within the introducer sheath due to a fractured sr wire, the introducer sheath friction lock was loose from the sheath and the sheath was ovalized.If the pod pc is forcefully manipulated against resistance, damage such as this may occur.Based on the reported complaint, the root cause of this damage 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.4316 - the investigation findings do not lead to a clear conclusion about the root cause of the reported complaint due to the return condition.

• Brand Name: POD PACKING COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 11489823
• Report Number: 3005168196-2021-00503
• Device Sequence Number: 5257519
• Product Code: HCG
• UDI-Device Identifier: 00814548016719
• UDI-Public: 00814548016719
• Combination Product (Y/N): Y
• Initial Reporter Country: GM
• PMA/510(K) Number: K141134
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/17/2021
• 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 Catalogue Number: RBYPODJ30
• Device Lot Number: F88723
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 02/17/2021
• Supplement Date Received by Manufacturer: 05/07/2021
• Initial Report FDA Received Date: 03/15/2021
• Supplement Report FDA Received Date: 05/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Date Report Sent to FDA: 01/01/2005