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

Catalog Number	RBYPCLP30
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of the returned packing coil lp confirmed the embolization coil was detached and was returned on the non-penumbra snare.Further evaluation revealed that the pusher assembly was kinked and fractured, and the embolization coil had offset coil winds.It was reported the coil was retracted and re-advanced in attempts to shape the coil.If the device is manipulated against resistance damage such as kinks and a subsequent fracture may occur.This damage likely contributed to the embolization coil detaching.Due to the offset coil winds, the reported coils inability to take shape could not be confirmed.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.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the left hepatic branch artery using packing coil lps and a non-penumbra microcatheter.It should be noted that the patient's anatomy was tortuous.During the procedure, the physician successfully implanted two non-penumbra coils into the target location.After advancing a packing coil lp into the target location, it was reported that the coil would not take its intended shape.The physician retracted the packing coil lp and re-advanced it into the target location; however, the issue was unresolved.The physician then decided to remove the packing coil lp and observed under fluoroscopy that the coil unintentionally detached partially in the patient's anatomy and mostly in the microcatheter.Therefore, the microcatheter was removed and a snare device was then used to successfully remove the detached packing coil lp.The procedure was successfully completed at this point and no additional coils were required.There was no report of an adverse effect to the patient.

• 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: 19923348
• Report Number: 3005168196-2024-00276
• Device Sequence Number: 15472469
• Product Code: HCG
• UDI-Device Identifier: 00815948021938
• UDI-Public: 00815948021938
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K192955
• 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
• Report Date (Section B): 08/06/2024
• 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: RBYPCLP30
• Device Lot Number: C00015088
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2024
• 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: 07/10/2024
• Initial Report FDA Received Date: 08/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/07/2022
• 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 Age: 72 YR
• Patient Sex: Male
• Date Report Sent to FDA: 01/01/2005