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

Catalog Number	RBYPCLP45
Medical Device Problem Codes	Fracture (1260); Unraveled Material (1664); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/17/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a coil embolization procedure in the subclavian collateral vein using a packing coil lp and a non-penumbra microcatheter.During the procedure, after advancing the packing coil lp into the target location, the physician noticed the proximal portion of the packing coil lp was too close to the ostium of the subclavian vein and decided to reposition the packing coil lp.After retracting approximately half of the packing coil lp back into the microcatheter, the physician experienced resistance and made multiple attempts to advance and retract the coil through the microcatheter but the coil would not respond.The physician attempted to remove the packing coil lp when the coil had unraveled and unintentionally detached from the pusher assembly.It was also reported the packing coil lp had fractured into separate segments after unraveling.Therefore, the physician clamped down on the microcatheter to remove the microcatheter and the packing coil lp together as unit; however, the attempt was unsuccessful.A snare device and another catheter were then used to remove fragments of the unraveled packing coil lp.A snare was used for several passes to remove portions of the unraveled packing coil lp.The physician determined that the remaining segment of the packing coil lp was in the intended location of the vessel.The procedure had ended at this point.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: 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: 19325731
• Report Number: 3005168196-2024-00186
• Device Sequence Number: 17795853
• Product Code: HCG
• UDI-Device Identifier: 00815948021945
• UDI-Public: 815948021945
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K192955
• 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): 05/15/2024
• 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 Expiration Date: 09/16/2026
• Device Catalogue Number: RBYPCLP45
• Device Lot Number: C00012337
• 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: 04/18/2024
• Initial Report FDA Received Date: 05/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/17/2021
• 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: 11 MO
• Patient Sex: Unknown
• Date Report Sent to FDA: 01/01/2005