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

Model Number	RBY2C1035-B
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/13/2020
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.This report is associated with mfr report numbers: 3005168196-2020-01116, 3005168196-2020-01117.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the splenic artery using pod coils, ruby coils, a ruby coil detachment handle (handle), and non-penumbra microcatheter.It was reported that the patient anatomy was tortuous.During the procedure, the physician advanced a pod coil to the target vessel using the microcatheter and attempted to detach the pod coil using the handle.However, the handle failed to attach the pod coil.Subsequently, the pod coil was removed, and the physician implanted two penumbra coils in the vessel.The physician then advanced the next pod coil and a ruby coil separately to the vessel, but the same issue occurred; the handle failed to detach the pod coil and ruby coil.Therefore, the pod coil and ruby coil were removed.The procedure was completed using another penumbra coil and the same handle.There was no report of an adverse effect to the patient.

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10376103
• Report Number: 3005168196-2020-01118
• Device Sequence Number: 2889425
• Product Code: HCG
• UDI-Device Identifier: 00814548019062
• UDI-Public: 00814548019062
• Combination Product (Y/N): Y
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: K173614
• 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
• Report Date (Section B): 07/13/2020
• 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 Model Number: RBY2C1035-B
• Device Catalogue Number: RBY2C1035
• Device Lot Number: F90628
• Was Device Available for Evaluation?: No
• 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: 07/13/2020
• Initial Report FDA Received Date: 08/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Date Report Sent to FDA: 01/01/2005