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

Model Number	RBYLP0430
Medical Device Problem Codes	Unraveled Material (1664); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of the first returned ruby coil lp confirmed that the embolization coil was detached from the pusher assembly.Further evaluation revealed that the pet lock was separated, the pull tube was not present on the proximal end of the pusher assembly, and the pull wire was in its initial position within the pusher assembly ddt.The separated pet lock and missing pull tube was likely a result of the manual detachment attempted during the procedure.The cause of the pull wire not being retracted out of the ddt could not be determined; however, this damage may have contributed to the embolization coil detachment issue during the procedure.Further evaluation also revealed pusher assembly kinks.This damage may be incidental to the reported complaint.Evaluation of the second returned ruby coil lp confirmed that the embolization coil was unraveled and had offset coil winds.If the device is forcefully manipulated against resistance, damage such as this may occur.The root cause of resistance during the procedure could not be determined.Further evaluation revealed that the pet lock was separated on the proximal end of the pusher assembly, and the pusher assembly had bend and kinks.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.This report is associated with mfr report number: 3005168196-2021-02015.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the hypogastric artery using ruby coil lps, a lp system detachment handle (handle), and a non-penumbra microcatheter.During the procedure, the physician advanced a ruby coil lp into the target vessel using the microcatheter and attempted to detach it using a handle; however, the ruby coil lp failed to detach.The physician then attempted to manually detach the ruby coil lp; however, it would not detach.Therefore, the physician decided to retract the ruby coil lp.While retracting the ruby coil lp, the physician experienced resistance and subsequently, the ruby coil lp detached inside the microcatheter.The physician then injected saline through the microcatheter to successfully push the detached ruby coil lp into the target location.While attempting to advance another ruby coil lp into the microcatheter, the physician experienced resistance and decided to remove the ruby coil lp.While removing the ruby coil lp, the ruby coil lp unraveled but the physician was able to remove the ruby coil lp out.The procedure was completed using a new ruby coil lp 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: 12457831
• Report Number: 3005168196-2021-02016
• Device Sequence Number: 14637502
• Product Code: HCG
• UDI-Device Identifier: 00815948021822
• UDI-Public: 00815948021822
• Combination Product (Y/N): Y
• Initial Reporter State: OR
• 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): 09/12/2021
• 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: 08/05/2025
• Device Model Number: RBYLP0430
• Device Catalogue Number: RBYLP0430
• Device Lot Number: F99374
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2021
• 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: 08/16/2021
• Initial Report FDA Received Date: 09/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 80 YR
• Date Report Sent to FDA: 01/01/2005