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 Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2021
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 number: 3005168196-2021-02017.
Event or Problem Description
The patient was undergoing a coil embolization procedure using ruby coil lps, an lp system detachment handle (handle), and a lantern delivery microcatheter (lantern).During the procedure, the physician successfully placed penumbra coils into the target location using the lantern.The physician then advanced a ruby coil lp into the target location using the lantern and attempted to detach it using the handle; however, the ruby coil lp failed to detach.Therefore, the ruby coil lp was removed.The procedure was completed using another penumbra coil lp and a new handle.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned ruby coil lp confirmed that the embolization coil was not detached from the pusher assembly and revealed that the pet lock was separated, and the pull wire was slightly retracted from its initial position.If the proximal end of the pusher assembly was not properly seated in the handle prior to detachment attempt, the pull wire may not completely retract from the pusher assembly distal detachment tip to detach the embolization coil.During functional testing, the ruby coil lp was able to be detached with the returned handle without issue.Further evaluation of the device revealed offset coil winds in the embolization coil and the kinks in the pusher assembly.This damage was likely incidental to the complaint.Evaluation of the returned handle revealed a functional and undamaged device.During functional testing, the handle was tested with a handle test fixture and performed within specification.The handle was able to detach a demonstration ruby coil lp without issue.Penumbra coils and handles 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.This report is associated with mfr report number: 3005168196-2021-02017.

• 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: 12457844
• Report Number: 3005168196-2021-02018
• Device Sequence Number: 4739404
• Product Code: HCG
• UDI-Device Identifier: 00815948021969
• UDI-Public: 00815948021969
• Combination Product (Y/N): Y
• Initial Reporter State: NJ
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2021
• 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: 09/13/2025
• Device Model Number: RLPH1
• Device Catalogue Number: RLPH1
• Device Lot Number: F100224
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 08/16/2021
• Supplement Date Received by Manufacturer: 09/14/2021
• Initial Report FDA Received Date: 09/12/2021
• Supplement Report FDA Received Date: 09/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Weight: 120
• Date Report Sent to FDA: 01/01/2005