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

Model Number	RBYPCLP60
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of the returned packing coil lp confirmed the embolization coil was detached from the pusher assembly.Further evaluation revealed that the pet lock was separated, and the pull wire was retracted out of the ddt.This is typically a sign of a successful detachment; however, there was no reported detachment attempt during the procedure; therefore, the cause of this damage could not be determined.If the pet lock is separated, and the pull wire is retracted, the embolization coil will detach.Further evaluation revealed offset coil winds throughout the length of the embolization coil.This damage was likely incidental to the reported complaint.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.(b)(4).
Event or Problem Description
The patient was undergoing a coil embolization procedure in the superior mesenteric artery using a packing coil lp and a microcatheter.During the procedure, the packing coil lp unintentionally detached in the microcatheter.Therefore, the microcatheter containing the detached packing coil lp was removed from the patient.No additional information regarding the completion of the procedure was provided.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
• MDR Report Key: 12510231
• Report Number: 3005168196-2021-02101
• Device Sequence Number: 3695355
• Product Code: HCG
• UDI-Device Identifier: 00815948021952
• UDI-Public: 00815948021952
• Combination Product (Y/N): Y
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K192955
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/21/2021
• 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: 03/07/2026
• Device Model Number: RBYPCLP60
• Device Catalogue Number: RBYPCLP60
• Device Lot Number: F104423
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2021
• 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: 08/26/2021
• Initial Report FDA Received Date: 09/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005