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

Catalog Number	RBYPODJ15
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	10/23/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.This report is associated with mfr report numbers: 1.3005168196-2023-00511, 2.3005168196-2023-00512, and 3.3005168196-2023-00513.
Event or Problem Description
The patient was undergoing a coil embolization procedure to treat a pulmonary arteriovenous malformation (avm) using a pod packing coils (pod pc), a non-penumbra catheter, a non-penumbra microcatheter, and a lantern delivery microcatheter (lantern).It was noted that the "patient's" anatomy was tortuous.During the procedure, the physician experienced resistance while advancing a pod pc (c00010017) through the non-penumbra microcatheter.It was reported that the pod pc was unable to reach the target vessel and unintentionally detached within the microcatheter.Therefore, the microcatheter containing the detached pod pc was removed, and the pod pc was removed from the microcatheter.The physician then reinserted the microcatheter into the patient and attempted to advance another pod pc (f00000758); however, the same issue occurred.Therefore, the detached pod pc and microcatheter were removed together.The physician then inserted a lantern into the patient and attempted to advance a pod pc (f00000869) through the lantern.However, resistance was encountered, and the pod pc unintentionally detached inside the lantern.Therefore, the lantern containing the detached pod pc was removed, and the pod pc was removed from the microcatheter.The physician then reinserted the lantern into the patient and attempted to advance another pod pc (f00000869); however, the same issue occurred.Therefore, the detached pod pc and lantern were removed together.The procedure was completed using a ruby coil and another microcatheter.There was no report of an adverse effect to the patient.

• 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: 18151680
• Report Number: 3005168196-2023-00514
• Device Sequence Number: 6061312
• Product Code: HCG
• UDI-Device Identifier: 00814548017648
• UDI-Public: 814548017648
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K170852
• 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
• Report Date (Section B): 11/16/2023
• 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: F00000869
• Was Device Available for Evaluation?: No
• 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: 10/23/2023
• Initial Report FDA Received Date: 11/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/20/2022
• 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: 67 YR
• Patient Sex: Male
• Date Report Sent to FDA: 01/01/2005