MAUDE Adverse Event Report: PENUMBRA, INC. LP SYSTEM DETACHMENT HANDLE; HCG, KRD

Model Number	RLPH1
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/05/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.This report is associated with mfr report numbers: 3005168196-2020-02159, 3005168196-2020-02160, 3005168196-2020-02161.
Event or Problem Description
The patient was undergoing a coil embolization procedure to treat an abdominal aortic aneurysm (aaa) endoleak using ruby coil lps, lp system detachment handles (handle), a non-penumbra microcatheter and catheter.During the procedure, the physician advanced a ruby coil lp into the target location using the microcatheter and used a handle to detach it; however, the ruby coil lp failed to detach.Therefore, the ruby coil lp and handle were removed.The physician then encountered the same issue with the next ruby coil lp and handle; therefore, the ruby coil lp and handle were also removed.The procedure was completed using other coils and the same microcatheter and catheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the second returned handle was undamaged.Conclusions: evaluation of the first returned ruby coil lp revealed that the pet lock was damaged and separated on its proximal end, but the pull wire was not retracted, and the embolization coil was intact with the pusher assembly and had offset coil winds.During functional testing, the ruby coil lp was attempted to be detached using the two returned handles but was unsuccessful.Further evaluation revealed an unknown substance within the pusher assembly ddt.The root cause of the unknown substance could not be determined; however, this damage may have contributed to the inability to detach the ruby coil lp during the procedure and the functional test.Evaluation of the second returned ruby coil lp could not confirm the reported complaint.The pet lock was separated and pull wire was retracted on the proximal end of the pusher assembly, and the embolization coil was detached.This is an indication of a successful detachment.Further evaluation revealed pusher assembly kinks throughout its length and offset coil winds along the embolization coil.This damage may be incidental to the reported complaint and may have occurred after removal from the procedure.Evaluation of the first returned handle revealed an undamaged, functional device.The handle was tested on a handle test fixture and performed within specification.Evaluation of the second returned handle revealed an undamaged, functional device.The handle was tested on a handle test fixture and performed within specification.Penumbra coils are inspected during in-process inspection and during quality inspection after manufacturing.Penumbra handles are 100% visually inspected and functionally tested during incoming quality inspection.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.This report is associated with mfr report numbers: 1.3005168196-2020-02159, 2.3005168196-2020-02160, and 3.3005168196-2020-02161.

• Brand Name: LP SYSTEM DETACHMENT HANDLE
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10933707
• Report Number: 3005168196-2020-02162
• Device Sequence Number: 13589560
• Product Code: HCG
• UDI-Device Identifier: 00815948021969
• UDI-Public: 00815948021969
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• 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,Followup
• Report Date (Section B): 11/05/2020
• 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: 08/10/2025
• Device Model Number: RLPH1
• Device Catalogue Number: RLPH1
• Device Lot Number: F99436
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 11/05/2020
• Supplement Date Received by Manufacturer: 12/11/2020
• Initial Report FDA Received Date: 12/02/2020
• Supplement Report FDA Received Date: 12/31/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 79 YR
• Date Report Sent to FDA: 01/01/2005