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

Catalog Number	RBYPODJ15
Medical Device Problem Codes	Failure to Fold (1255); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of the returned pod pc confirmed that the embolization coil was detached from its pusher assembly.Evaluation revealed that the pusher assembly was kinked and fractured, the pull wire was retracted out of the distal tip of the pusher assembly.If the pod pc is manipulated against resistance, damage such as a kink and subsequent fracture may occur.Based on the reported event, the patient anatomy was tortuous and calcified.This likely contributed to resistance during the procedure.Further evaluation revealed bends along the length of the pusher assembly and offset coil winds on the embolization coil.This damage was incidental to the reported complaint and may have occurred during packaging of the device for return.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.H3 other text : placeholder.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the internal iliac artery (iia) using pod packing coils (pod pc), a lantern delivery microcatheter (lantern), and a 4f catheter.It was noted that the patient¿s anatomy was moderately tortuous and calcified.During the procedure, the physician successfully implanted a non-penumbra coil and three pod pcs into the target vessel using the lantern.The physician then advanced a new pod pc through the lantern and into the target vessel.However, the pod pc would not form in the target vessel.After multiple attempts to form the pod pc in the target vessel, the pod pc unintentionally detached within the lantern.Therefore, the lantern containing the pod pc was removed.The procedure was completed using a new pod pc and the same lantern.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: 17638179
• Report Number: 3005168196-2023-00409
• Device Sequence Number: 18065322
• Product Code: HCG
• UDI-Device Identifier: 00814548017648
• UDI-Public: 814548017648
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K170852
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/28/2023
• 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: F00005796
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2023
• 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: 08/04/2023
• Initial Report FDA Received Date: 08/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/02/2023
• 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 Sex: Unknown
• Date Report Sent to FDA: 01/01/2005