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

Model Number	RBYLP0406
Medical Device Problem Code	Failure to Fold (1255)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/21/2020
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 number: 3005168196-2020-01459.
Event or Problem Description
The patient was undergoing a coil embolization procedure in an arteriovenous fistula (avf) using ruby coil lps, guide catheter and non-penumbra microcatheter.It was noted that the patient¿s anatomy was tortuous.During the procedure, the physician advanced a ruby coil lp into the vessel using the microcatheter; however, the ruby coil lp would not take its intended shape.The physician repositioned the microcatheter and attempted to advance the ruby coil lp; however, the coil still would not take its intended shape.Therefore, it was removed.The physician then advanced another ruby coil lp into the vessel; however, after multiple attempts, the same issue occurred and, therefore, the ruby coil lp was removed.The procedure was completed using a new ruby coil lp, same microcatheter and same guide catheter.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: 10523441
• Report Number: 3005168196-2020-01458
• Device Sequence Number: 17050007
• Product Code: HCG
• UDI-Device Identifier: 00815948021808
• UDI-Public: 00815948021808
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• 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): 08/21/2020
• 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: 01/13/2025
• Device Model Number: RBYLP0406
• Device Catalogue Number: RBYLP0406
• Device Lot Number: F95588
• 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: 08/21/2020
• Initial Report FDA Received Date: 09/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 35 YR
• Date Report Sent to FDA: 01/01/2005