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

Model Number	RBY2C0725-B
Medical Device Problem Code	Failure to Fold (1255)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/03/2020
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: 3005168196-2020-01314, 3005168196-2020-01315.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the splenic artery using pod coils, a ruby coil, and a lantern delivery microcatheter (lantern).During the procedure, the physician advanced a pod coil into the target location using the lantern; however, the pod6 coil would not take its intended shape or would migrate distally.Therefore, the pod6 coil was removed.The physician then advanced a pod5 coil into the target location using the lantern; however, the pod coil would not take its intended shape or would migrate distally.Therefore, the pod5 coil was removed.Then, the physician advanced a ruby coil into the target location using the lantern; however, the same issue occurred.Therefore, the ruby coil was removed.The procedure was completed using a pod6 coil and the same lantern.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: 10466835
• Report Number: 3005168196-2020-01316
• Device Sequence Number: 11536332
• Product Code: HCG
• UDI-Device Identifier: 00814548018836
• UDI-Public: 00814548018836
• Combination Product (Y/N): Y
• Initial Reporter State: NY
• 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
• Report Date (Section B): 08/03/2020
• 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 Expiration Date: 05/14/2026
• Device Model Number: RBY2C0725-B
• Device Catalogue Number: RBY2C0725
• Device Lot Number: F83476
• 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: 08/03/2020
• Initial Report FDA Received Date: 08/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 36 YR
• Date Report Sent to FDA: 01/01/2005