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

Model Number	RBYLP0315
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/07/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of the returned ruby coil lp confirmed that the embolization coil was unable to be detached from the pusher assembly.Evaluation revealed that the pet lock was separated, the pull wire was fractured at its distal end and the proximal end of the pusher assembly was damaged.These damages were likely a result of the forceful coil detachment attempt during the procedure.Further evaluation of the device revealed that the pusher assembly was fractured and kinked, and the embolization coil had offset coil winds.These damages were likely incidental to the compliant and may have occurred during packaging for the device return.Due to the pusher assembly damage, the device was unable to be functionally tested.Evaluation of the returned ruby coil lp confirmed that the embolization coil was unable to be detached from the pusher assembly.Evaluation revealed that the pet lock was separated, and the pull wire was fractured at its distal end.These damages were likely a result of the forceful coil detachment attempt during the procedure.Further evaluation of the device revealed that the pusher assembly was kinked, and the embolization coil had offset coil winds.These damages were likely incidental to the compliant and may have occurred during packaging for the device return.Due to the pusher assembly damage, the device was unable to be functionally tested.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).This report is associated with mfr report number: 3005168196-2021-02481.
Event or Problem Description
The patient was undergoing a coil embolization procedure to treat a gastrointestinal bleed (gi bleed) using ruby coil lps, an lp system detachment handle (handle), and a non-penumbra microcatheter.During the procedure, the physician advanced a ruby coil lp into the target location and attempted to detach it using a handle; however, the ruby coil lp failed to detach.Therefore, the ruby coil lp was removed.Subsequently, the physician advanced another ruby coil lp and attempted to detach it using a handle; however, the same issue occurred.Therefore, the ruby coil lp was removed.It was also reported that the physician noticed the detachment zone on the proximal end for both ruby coil lps was slightly separated.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: RUBY COIL LP
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 12741313
• Report Number: 3005168196-2021-02482
• Device Sequence Number: 5936919
• Product Code: HCG
• UDI-Device Identifier: 00815948021792
• UDI-Public: 00815948021792
• Combination Product (Y/N): Y
• Initial Reporter State: NC
• 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): 11/02/2021
• 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: 06/08/2026
• Device Model Number: RBYLP0315
• Device Catalogue Number: RBYLP0315
• Device Lot Number: F106972
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2021
• 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: 10/08/2021
• Initial Report FDA Received Date: 11/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 76 YR
• Date Report Sent to FDA: 01/01/2005