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

Catalog Number	RBYPODJ15
Medical Device Problem Codes	Break (1069); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/18/2022
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.This report is associated with mfr report number: 3005168196-2022-00538.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the gastroduodenal artery (gda) using pod packing coils (pod pc), pod coils, and a lantern delivery microcatheter (lantern).During the procedure, the physician placed multiple pod pcs and pod coils in the target location using the lantern.The physician advanced and detached another pod pc in the target location.Subsequently, while removing the pusher assembly of the pod pc, the physician noticed the pusher assembly had broken off within the lantern and became stuck.Therefore, the lantern containing the broken pusher assembly of the pod pc was removed.It was reported after removing the lantern, the hospital technologist noticed the lantern was stiff where the pusher assembly had broken off and became stuck.The lantern was not used for the remainder of the procedure.Next, the physician inserted a new lantern into the patient and then advanced the next pod pc through the lantern.While attempting to form the pod pc in the desired location, the coil had unintentionally detached.It was reported that the pod pc detached in the desired location; therefore, the physician removed the pusher assembly and flushed the lantern to secure the coil in the vessel.The procedure was completed using additional pod pcs and the same lantern.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that this complaint was submitted to the fda by the user facility with the following reference number: mw5112797.This report is associated with mfr report number: 3005168196-2022-00538.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the gastroduodenal artery (gda) using pod packing coils (pod pc), pod coils, and a lantern delivery microcatheter (lantern).During the procedure, the physician placed multiple pod pcs and pod coils in the target location using the lantern.The physician advanced and detached another pod pc in the target location.Subsequently, while removing the pusher assembly of the pod pc, the physician noticed the pusher assembly had broken off within the lantern and became stuck.Therefore, the lantern containing the broken pusher assembly of the pod pc was removed.It was reported after removing the lantern, the hospital technologist noticed the lantern was stiff where the pusher assembly had broken off and became stuck.The lantern was not used for the remainder of the procedure.Next, the physician inserted a new lantern into the patient and then advanced the next pod pc through the lantern.While attempting to form the pod pc in the desired location, the coil had unintentionally detached.It was reported that the pod pc detached in the desired location; therefore, the physician used the pusher assembly to push and secure the pod pc in the vessel.The procedure was completed using additional pod pcs and the same lantern.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 12/1/2022: 1.Section b.Box 5.Describe event or problem.This report is associated with mfr report number: 3005168196-2022-00538 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: 15820104
• Report Number: 3005168196-2022-00539
• Device Sequence Number: 16896627
• Product Code: HCG
• UDI-Device Identifier: 00814548017648
• UDI-Public: 814548017648
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K170852
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/12/2022
• 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: RBYPODJ15
• Device Lot Number: F00002619
• 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: 10/24/2022
• Supplement Date Received by Manufacturer: 12/01/2022; 01/14/2005
• Initial Report FDA Received Date: 11/17/2022
• Supplement Report FDA Received Date: 12/07/2022; 12/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/16/2022
• 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