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

Catalog Number	RBYPCLP10
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	07/25/2024
Type of Reportable Event	Malfunction
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.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the right renal artery using a packing coil lp and a non-penumbra microcatheter.During the procedure, the physician successfully placed two packing coil lps in the target vessel.It was noted that the catheter was flushed with saline between each coil.While advancing the next packing coil lp, the physician encountered resistance.Subsequently, the coil unintentionally detached within the microcatheter.Therefore, physician removed the microcatheter containing the detached packing coil lp.The coil was flushed out on the back table.The procedure was completed using additional packing coil lps and the same microcatheter.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 right renal artery using a packing coil lp and a non-penumbra microcatheter.During the procedure, the physician successfully placed two packing coil lps in the target vessel.It was noted that the catheter was flushed with saline between each coil.While advancing the next packing coil lp, the physician encountered resistance.Subsequently, the coil unintentionally detached within the microcatheter.Therefore, physician removed the microcatheter containing the detached packing coil lp.The procedure was completed using additional packing coil lps and a new microcatheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the following section was incorrectly reported on the initial mfr report and is being corrected on this follow-up #1 mfr report.1.Section b.Box 5.Describe event or problem evaluation of the returned packing coil lp confirmed the embolization coil was detached from the pusher assembly.Evaluation revealed that the pusher assembly was fractured, and the distal fractured segment was within the returned non-penumbra microcatheter.If the device is advanced against resistance, damage such as a kink and subsequent fracture may occur.If the pusher assembly is fractured, the pull wire will retract from the distal tip and allow the embolization coil to detach.Further evaluation revealed pusher assembly kinks, and the detached embolization coil was alongside the pusher assembly within the non-penumbra microcatheter.The pusher assembly kinks may be incidental to the complaint and may have occurred during packaging for return to penumbra.The cause of the detached embolization coil being on the side of the pusher assembly could not be determined.A slight ovalization was noticed on the distal shaft of the non-penumbra microcatheter.However, due to the fractured packing coil lp pusher assembly and inability to remove the embolization coil from the non-penumbra catheter, no further testing could be performed.Therefore, it is unable to determine if the damage on the non-penumbra catheter contributed to any resistance during the procedure.Penumbra coils are 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: PACKING COIL LP
• 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: 20007848
• Report Number: 3005168196-2024-00285
• Device Sequence Number: 17233959
• Product Code: HCG
• UDI-Device Identifier: 00815948026162
• UDI-Public: 00815948026162
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K230284
• 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,Followup
• Report Date (Section B): 08/30/2024
• 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: RBYPCLP10
• Device Lot Number: F00009235
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2024
• 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: 07/25/2024
• Supplement Date Received by Manufacturer: 08/23/2024
• Initial Report FDA Received Date: 08/20/2024
• Supplement Report FDA Received Date: 08/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/30/2023
• 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 Age: 53 YR
• Patient Sex: Female
• Date Report Sent to FDA: 01/01/2005