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

Catalog Number	RBYPODJ30
Medical Device Problem Codes	Physical Resistance/Sticking (4012); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/23/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a coil embolization procedure to treat a feeding artery of a pulmonary arteriovenous malformation (pavm) using a lantern delivery microcatheter (lantern), a pod packing coil (podj), a non-penumbra vascular plug, a non-penumbra guiding catheter, and a non-penumbra sheath.During the procedure, the physician placed the sheath in the pulmonary artery.The physician then advanced the vascular plug in the feeding artery using the guiding catheter, lantern, and sheath.A contrast over the sheath was done to check if there was still flow right after the feeding artery.Since, there was still flow, the physician decided to pull in one of the two vascular plug chambers into the guiding catheter.The physician then advanced the lantern to the partially released vascular plug and inserted the podj.The podj advanced through its introducer sheath and into the lantern effortlessly under continuous flush.Once the podj advanced out of the distal end of the lantern, the physician experienced resistance and the podj immediately faced the vascular plug.The podj then made a 180 degree turn back into the feeding artery.At this point, the podj was pushed no more than approximately five centimeters out of the distal end of the lantern and when the physician attempted to retract the podj, it was noticed that the podj had unintentionally detached inside the lantern.Therefore, the lantern containing the detached podj was removed.The procedure was completed by placing the second chamber of the vascular plug over the same guiding catheter.A complete occlusion of the feeding artery was achieved no coiling was needed.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.
Additional Manufacturer Narrative
Evaluation of the returned pod pc revealed that the embolization coil was detached due to an sr wire fracture, and the complaint was confirmed.If the device is forcefully retracted against resistance, damage such as this may occur.The ovalization in the returned lantern may have contributed to the resistance experienced during the procedure.Further evaluation of the device revealed that the pusher assembly was kinked near its distal tip and the embolization coil was unraveled.The kinked pusher assembly was likely due to forceful manipulation of the device against resistance, and the unraveled coil was likely due to the sr wire fracture.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
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 13041499
• Report Number: 3005168196-2021-02788
• Device Sequence Number: 19280788
• Product Code: HCG
• UDI-Device Identifier: 00814548016719
• UDI-Public: 00814548016719
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K141134
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/09/2022
• 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: F94301
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2022
• Is the Reporter a Health Professional?: Yes
• 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: 11/23/2021
• Supplement Date Received by Manufacturer: 02/16/2022
• Initial Report FDA Received Date: 12/20/2021
• Supplement Report FDA Received Date: 03/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/18/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Weight: 80 KG
• Date Report Sent to FDA: 01/01/2005