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

Model Number	RBYLP0315
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/20/2021
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.During functional testing, the ruby coil lp was attempted to be detached with a demonstration handle but was unsuccessful.The device was unable to be manually detached as well.The root cause of the detachment issue could not be determined.Further evaluation of the device revealed that the pet lock was separated, and the embolization coil had offset coil winds.The damaged pet lock was likely a result of the detachment attempt during the procedure.The offset coil winds on the embolization coil was likely incidental to the 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.Conclusions code 1: (b)(4): the investigation findings do not lead to a clear conclusion about the root cause of ruby coil lp detachment issue.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the splenic artery using ruby coil lps and a lp system detachment handle (handle).During the procedure, a ruby coil lp would not detach with the handle.The physician then attempted to use a hemostat to detach the ruby coil lp but was unsuccessful.Therefore, the ruby coil lp was removed.The procedure was completed using six new ruby coil lps and the same handle.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: 11832482
• Report Number: 3005168196-2021-01055
• Device Sequence Number: 16937126
• Product Code: HCG
• UDI-Device Identifier: 00815948021792
• UDI-Public: 00815948021792
• Combination Product (Y/N): Y
• Initial Reporter State: NV
• 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): 04/20/2021
• 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: 01/11/2026
• Device Model Number: RBYLP0315
• Device Catalogue Number: RBYLP0315
• Device Lot Number: F103233
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2021
• 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: 04/20/2021
• Initial Report FDA Received Date: 05/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Weight: 65
• Date Report Sent to FDA: 01/01/2005