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

Catalog Number	RBYPCLP15
Medical Device Problem Code	Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/09/2023
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.H3 other text : placeholder.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the ileocolic artery using a ruby coil lp, packing coil lps, an lp system detachment handle (handle), and a non-penumbra microcatheter.During the procedure, the physician placed one ruby coil lp and two packing coil lps in the vessel.The physician then advanced the last packing coil lp into the target location and made an attempt to detach it using the handle.It was reported that the physician thought the packing lp was detached in the vessel.However, while retracting the pusher assembly, it was noted that the packing coil lp was still attached to the pusher assembly.The packing coil lp unintentionally detached inside the microcatheter with the distal end of the coil partially outside the microcatheter.Therefore, the microcatheter containing the detached packing coil lp was removed.The physician was satisfied with the coils placed in the vessel and ended the procedure at this point.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: 18066433
• Report Number: 3005168196-2023-00492
• Device Sequence Number: 7684634
• Product Code: HCG
• UDI-Device Identifier: 00815948021921
• UDI-Public: 815948021921
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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): 11/03/2023
• 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: RBYPCLP15
• Device Lot Number: F00007000
• 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: 10/12/2023
• Initial Report FDA Received Date: 11/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2023
• 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: 65 YR
• Patient Sex: Female
• Date Report Sent to FDA: 01/01/2005