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

Model Number	RBY4C0202-B
Medical Device Problem Code	Failure to Fold (1255)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.This report is associated with mfr report number: 3005168196-2020-00517.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the gastrointestinal (gi) region using ruby coils, packing coil lps, a lantern delivery microcatheter (lantern), and non-penumbra microcatheter.During the procedure, the physician advanced a ruby coil to the target vessel using the lantern and attempted to place it, but the ruby coil was not taking its intended shape.The physician then decided to re-sheath the ruby coil, but it had formed a knot; therefore, the ruby coil was removed and not used for the remainder of the procedure.The physician then advanced a packing coil lp to the vessel using another microcatheter and attempted to place it, but the same issue occurred; therefore, the packing coil lp was also removed.The procedure was completed using another packing coil lp and the same microcatheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the device in complaint was expected to be returned; however, additional information received from the penumbra sales representative indicated that the device was disposed of and is no longer available for return.Therefore, without the return of the device, the root cause of the problem cannot be determined.This report is associated with mfr report number: 3005168196-2020-00517.

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 9926187
• Report Number: 3005168196-2020-00518
• Device Sequence Number: 3296754
• Product Code: HCG
• UDI-Device Identifier: 00814548018263
• UDI-Public: 00814548018263
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2020
• 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: RBY4C0202-B
• Device Catalogue Number: RBY4C0202
• Device Lot Number: F92518
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 03/10/2020
• Supplement Date Received by Manufacturer: 07/16/2020
• Initial Report FDA Received Date: 04/04/2020
• Supplement Report FDA Received Date: 07/31/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Date Report Sent to FDA: 01/01/2005