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

Catalog Number RBYPODJ60

Device Problems Physical Resistance/Sticking (4012); Premature Separation (4045)

Patient Problems Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/03/2022

Event Type  malfunction  

Event Description

The patient was undergoing a coil embolization procedure in the lumbar artery off the right internal artery using a pod packing coil (pod pc), a pod coil, a lantern delivery microcatheter (lantern), a non-penumbra sheath and a non-penumbra diagnostic catheter.During the procedure, the physician successfully placed the pod coil in the target vessel.Next, the physician attempted to place the pod pc in the target vessel and found that it was too long.While removing the pod pc, the physician encountered resistance and the pod pc unintentionally detached partially in the lantern and partially in the vessel.The physician attempted to remove the lantern and the pod pc together; however, the lantern was removed but the pod pc remained inside the vessel and the sheath.Subsequently, while attempting to remove the detached pod pc using a snare device, the coil broke and only part of the coil was removed.It was reported that the remaining part of the coil was left in the target vessel and filament wire was found in the internal iliac pseudoaneurysm.The physician attempted to snare the pod pc filament and the remaining coil but was unsuccessful.The procedure ended at this point.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Evaluation of the returned pod pc embolization coil confirmed that the coil was fractured.This damage likely occurred due to snaring the device during removal from the patient.The pusher assembly was not returned for evaluation, and therefore, the root cause of the embolization coil detaching during the procedure 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.Section h.Box 6.Conclusions code 1: 4316 - the investigation findings do not lead to a clear conclusion about the root cause of the pod pc detachment.

• Brand Name: POD PACKING COIL
• Type of Device: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 15686770
• MDR Text Key: 305177998
• Report Number: 3005168196-2022-00502
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548017679
• UDI-Public: 814548017679
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170852
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/01/2005,10/27/2022

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
• Device Operator: Health Professional
• Device Catalogue Number: RBYPODJ60
• Device Lot Number: F00001250
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Initial Date Manufacturer Received: 10/03/2022
• Initial Date FDA Received: 10/27/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/07/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 76 YR
• Patient Sex: Male