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

Catalog Number	RBYPOD14
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	04/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a coil embolization procedure in the splenic artery using a pod coil, a lantern delivery microcatheter (lantern), and a non-penumbra base catheter.During the procedure, the physician advanced the lantern through the non-penumbra base catheter to the target location.While attempting to advance a pod coil through the lantern, the physician experienced resistance, and the pod coil would not exit the distal end of the lantern.Therefore, the physician decided to retract the pod coil.While retracting the pod coil, the physician met resistance, and the pod coil unintentionally detached inside the lantern.It was reported that the non-penumbra base catheter was pinching into the lantern on one of the turns in the splenic artery that caused the mid-distal portion of the lantern to kink.Therefore, the lantern containing the detached pod coil was removed from the patient.The procedure was completed using two non-penumbra coils and the same non-penumbra base catheter.There was no report of an adverse effect to the patient.
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.

• 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: 19243621
• Report Number: 3005168196-2024-00172
• Device Sequence Number: 7439802
• Product Code: HCG
• UDI-Device Identifier: 00814548019673
• UDI-Public: 814548019673
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K173614
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/03/2024
• 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: RBYPOD14
• Device Lot Number: F00001481
• 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: 04/11/2024
• Initial Report FDA Received Date: 05/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/16/2022
• 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