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

Catalog Number	RBYPODJ45
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	02/28/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.H3 other text : placeholder.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the inferior mesenteric artery (ima) using a packing coil (pc) and a lantern delivery microcatheter (lantern).It should be noted that the patient¿s anatomy was mildly tortuous.During the procedure, while attempting to advance the pc into the target vessel, the physician determined that the pc did not fit in the vessel.While retracting the pc through the mid-shaft of the lantern, resistance was encountered, and the pc unintentionally detached.Therefore, the lantern containing the detached pc was removed.It was reported that the pc was flushed out of the lantern.The procedure was completed using a new pc and the same lantern.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned pod packing coil confirmed that the embolization coil was detached.Evaluation revealed that the pet lock was intact on the proximal end of the pusher assembly, and the pull wire was in its original position on the distal end of the pusher assembly.If the pod packing coil is retracted against resistance, the pusher assembly may elongate beyond the reach of the pull wire and result in the embolization coil detachment.Further evaluation revealed kinks and 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 the root cause 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.

• 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: 19028271
• Report Number: 3005168196-2024-00120
• Device Sequence Number: 12517523
• Product Code: HCG
• UDI-Device Identifier: 00814548017662
• UDI-Public: 814548017662
• 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,Followup
• Report Date (Section B): 04/10/2024
• 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: RBYPODJ45
• Device Lot Number: F114081
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2024
• 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: Not provided
• Supplement Date Received by Manufacturer: 03/29/2024
• Initial Report FDA Received Date: 04/02/2024
• Supplement Report FDA Received Date: 04/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/31/2022
• 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 Sex: Unknown
• Date Report Sent to FDA: 01/01/2005