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

Catalog Number	RBYPCLP45
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2024
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 sigmoid artery off the inferior mesenteric artery (ima) using ruby coil lps, packing coil lp, an lp system detachment handle (handle), and a non-penumbra microcatheter.During the procedure, the physician advanced a ruby coil lp into the target vessel and attempted to detach it using the handle; however, the ruby coil lp failed to detach.To troubleshoot, the physician attempted to manually detach the ruby coil using a hemostat, but the ruby coil lp still would not detach.Therefore, the ruby coil lp was removed.The same issue occurred with the next ruby coil lp.The physician then advanced a packing coil lp into the target location; however, when attempting to reposition the packing coil lp, the coil unintentionally detached inside the microcatheter.Therefore, the microcatheter containing the detached packing coil lp was removed and the coil was flushed out.The physician reinserted the same microcatheter back into the vessel and placed a ruby coil lp, but the coil would not detach using the handle.It was also reported that the same troubleshooting attempts were made to detach the ruby coil lp, but the coil still failed to detach.The ruby coil lp was therefore removed.The procedure was completed using new ruby coil lps with the same handle and microcatheter.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: 18914509
• Report Number: 3005168196-2024-00090
• Device Sequence Number: 6759862
• Product Code: HCG
• UDI-Device Identifier: 00815948026193
• UDI-Public: 815948026193
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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
• Report Date (Section B): 03/15/2024
• 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 Catalogue Number: RBYPCLP45
• Device Lot Number: F00008720
• 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: 02/19/2024
• Initial Report FDA Received Date: 03/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/27/2023
• 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: 85 YR
• Patient Sex: Male
• Date Report Sent to FDA: 01/01/2005