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

Catalog Number	RBYPODJ15
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/26/2021
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 in the splenic artery using a ruby coil detachment handle (handle), pod packing coils (podj), a non-penumbra microcatheter, and a non-penumbra sheath.During the procedure, the physician detached the initial coils in the target vessel using the handle.The physician then advanced a podj into the target vessel and used the handle to detach it; however, the podj failed to detach after multiple attempts.Therefore, the podj was removed.The procedure was completed using the same handle and additional coils.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned pod pc confirmed the embolization coil was still intact with the pusher assembly.Further evaluation revealed that the pet lock was separated, the pull wire was retracted, but the embolization coils proximal constraint sphere was still within the pusher assembly ddt.During functional testing, the embolization coil was able to be removed from the pusher assembly ddt with resistance due to the proximal constraint sphere being stuck to the ddt initially.The root cause of the proximal constraint sphere sticking to the ddt could not be determined.Further evaluation also revealed offset coil winds.This damage was likely incidental to the reported complaint.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.Section h.Box 6.Conclusions code 1: 4316 - the investigation findings do not lead to a clear conclusion about the root cause of the reported complaint.

• Brand Name: POD PACKING COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 11734467
• Report Number: 3005168196-2021-00882
• Device Sequence Number: 3765084
• Product Code: HCG
• UDI-Device Identifier: 00814548016702
• UDI-Public: 00814548016702
• 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): 03/31/2021
• 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: RBYPODJ15
• Device Lot Number: F100033
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 03/31/2021
• Supplement Date Received by Manufacturer: 05/25/2021
• Initial Report FDA Received Date: 04/27/2021
• Supplement Report FDA Received Date: 05/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 46 YR
• Date Report Sent to FDA: 01/01/2005