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

Catalog Number	RBYLP0415
Medical Device Problem Codes	Migration (4003); Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/07/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the proximal gastroduodenal artery (gda) using a ruby coil lp and a microcatheter.It should be noted that the patient's anatomy was minimally tortuous.During the procedure, the physician advanced the first ruby coil lp into the target location and attempted to detach the coil manually; however, the ruby coil lp did not detach.The physician made multiple attempts to detach the ruby coil lp by pulling harder on the pull wire.The physician then noticed under fluoroscopy that the ruby coil lp eventually detached by retracting the pusher assembly.However, approximately five centimeters of the coil still remained in the microcatheter.The physician then used saline to flush the remaining part of the ruby coil lp into the target vessel.It was reported that the ruby coil lp was unstable and migrated to a more distal position of the gda.The physician decided to leave the ruby coil lp in the distal part of the gda since there were enough collateral vessels in the surrounding area that would provide perfusion.The procedure was completed using two additional ruby coil lps and the same microcatheter.It was reported there was no 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
• Manufacturer (Section G): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 21049596
• Report Number: 3005168196-2024-00429
• Device Sequence Number: 3409210
• Product Code: HCG
• UDI-Device Identifier: 00815948021815
• UDI-Public: 00815948021815
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K192955
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/31/2024

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 Catalogue Number: RBYLP0415
• Device Lot Number: F112502
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/08/2024
• Initial Report FDA Received Date: 12/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/31/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Sex: Female