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

Catalog Number	RBYPODJ45
Medical Device Problem Codes	Break (1069); Physical Resistance/Sticking (4012); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a coil embolization procedure in the pulmonary artery to treat pulmonary arteriovenous malformations using pod packing coils (packing coil), ruby coils, a non-penumbra microcatheter, and a non-penumbra catheter.It should be noted that the patient¿s anatomy was mildly tortuous.During the procedure, the physician successfully implanted three ruby coils and five packing coils into the target vessel using the microcatheter.While advancing the distal part of another packing coil past the hub of the microcatheter, the physician experienced resistance.While continuing to advance the packing coil against resistance through the proximal length of the microcatheter, the physician fractured the pusher assembly of the packing coil and the packing coil unintentionally detached within the microcatheter.Therefore, the microcatheter containing the detached packing coil was removed.The procedure was completed using a new packing coil.There was no report of an adverse effect to the patient.
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.
Additional Manufacturer Narrative
Evaluation of the returned pod packing coil (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pet lock was intact on the proximal end of the pusher assembly, the pusher assembly was fractured, and the pull wire was retracted from its original position on the distal tip of the pusher assembly.If packing coil is advanced against resistance, damage such as a kink and subsequent fracture may occur.Upon further manipulation of the fractured device, the pull wire may retract from its original position on the distal tip of the pusher assembly, and the embolization coil may detach from its pusher assembly.Further evaluation revealed kinks along the length of the pusher assembly.This damage was incidental to the reported complaint and likely occurred during packaging of the device for returned to penumbra.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.H3 other text : placeholder.

• 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: 19325776
• Report Number: 3005168196-2024-00187
• Device Sequence Number: 19475209
• 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): 05/24/2024
• 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: F00009250
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2024
• 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: 04/24/2024
• Supplement Date Received by Manufacturer: 05/18/2024
• Initial Report FDA Received Date: 05/15/2024
• Supplement Report FDA Received Date: 05/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/31/2023
• 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