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

Catalog Number	RBYPOD8
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	10/19/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a coil embolization procedure in the brachial vein to treat an arteriovenous fistula (avf) using a pod coil and a non-penumbra microcatheter.It was reported that the patient¿s anatomy was slightly tortuous.During the procedure, while advancing the pod coil through the distal end of the microcatheter, the physician experienced resistance, and subsequently, the pod coil unintentionally detached within the microcatheter.Therefore, the microcatheter containing the detached pod coil was removed from the patient.Afterwards, the physician performed an angiogram which showed good blood flow in the avf.The physician then decided not to block the brachial vein and the procedure ended at this point.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 coil confirmed that the embolization coil was detached from the pusher assembly.Evaluation revealed that the pet lock was intact on the proximal end of the pusher assembly, and the pull wire was within its initial position.If the pod coil is manipulated against resistance during use, the pusher assembly may elongate beyond the reach of the pull wire, and result in the embolization coil detaching from the pusher assembly.Further evaluation revealed kinks throughout the length of the pusher assembly.This damage was incidental to the reported complaint and may have occurred during packaging of the device for return 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
• 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: 15794455
• Report Number: 3005168196-2022-00534
• Device Sequence Number: 3113538
• Product Code: HCG
• UDI-Device Identifier: 00814548013831
• UDI-Public: 814548013831
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• 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): 01/19/2023
• 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: RBYPOD8
• Device Lot Number: F103450
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 10/20/2022
• Supplement Date Received by Manufacturer: 01/06/2023
• Initial Report FDA Received Date: 11/14/2022
• Supplement Report FDA Received Date: 01/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/22/2021
• 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: 56 YR
• Patient Sex: Male
• Date Report Sent to FDA: 01/01/2005