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

Catalog Number	RBYPOD4
Medical Device Problem Codes	Break (1069); Unraveled Material (1664); Migration (4003)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/24/2022
Type of Reportable Event	Malfunction
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.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the splenic artery using pod coils, a non-penumbra microcatheter, and a non-penumbra catheter.During the procedure, the physician placed a pod coil in the target vessel using the microcatheter.The physician placed another pod coil in the vessel and then removed the microcatheter and catheter.Subsequently, a fluoroscopy was performed, and the physician noticed the tail end of the pod coil (pod4) was dislodged and migrated into the hepatic artery.The following day, the physician attempted to use a snare device to remove the pod coil that migrated into the hepatic artery.However, while snaring the tip of the pod coil, the physician noticed the pod coil broke and started to unravel.It was reported that small strands of the pod coil were being pulled out and majority of the strands were removed using the snare, but a small residual strand remained in the vessel that extends to the iliac.The physician ended the procedure at this point and the patient was sent to undergo a computed tomography (ct).There was no report of an adverse effect to the patient.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the splenic artery using pod coils, a non-penumbra microcatheter, and a non-penumbra catheter.During the procedure, the physician placed a pod coil in the target vessel using the microcatheter.The physician placed another pod coil in the vessel and then removed the microcatheter and catheter.Subsequently, a fluoroscopy was performed, and the physician noticed the tail end of the pod coil (pod4) was dislodged and migrated into the hepatic artery.The bleed in the target location had stopped and the physician ended the procedure at this point.The following day, the physician attempted to use a snare device to remove the pod coil that migrated into the hepatic artery.However, while snaring the tip of the pod coil, the physician noticed the pod coil broke and started to unravel.It was reported that small strands of the pod coil were being pulled out and majority of the strands were removed using the snare, but a small residual strand remained in the vessel that extends to the iliac.It was reported that the physician determined the small residual strand was safe and decided to leave it in place.The physician ended the procedure at this point and the patient was sent to undergo a computed tomography (ct).There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the following section is being updated based on additional information provided by a penumbra sales representative on 01/25/2023: 1.Section b.Box 5.Describe event or problem 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: 16211419
• Report Number: 3005168196-2023-00035
• Device Sequence Number: 11844018
• Product Code: HCG
• UDI-Device Identifier: 00814548019598
• UDI-Public: 814548019598
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K141134
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/04/2023
• 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: RBYPOD4
• Device Lot Number: F111513
• 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: 12/25/2022
• Supplement Date Received by Manufacturer: 01/25/2023
• Initial Report FDA Received Date: 01/19/2023
• Supplement Report FDA Received Date: 05/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/16/2021
• 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: 47 YR
• Patient Sex: Female
• Date Report Sent to FDA: 01/01/2005