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

Catalog Number	RBY2C2060
Medical Device Problem Codes	Failure to Advance (2524); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/02/2019
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: 3005168196-2019-01070.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the right hypogastric artery using ruby coils and a lantern delivery microcatheter (lantern).During the procedure, the physician advanced a ruby coil to the distal end of the lantern and experienced resistance.The ruby coil was then retracted and re-advanced within the lantern, however, resistance was experienced when retracting and re-advancing near the distal end of the lantern.Subsequently, the ruby coil became stuck inside the lantern.An attempt was made to remove the ruby coil from the lantern, but the ruby coil was starting to become damaged.Therefore, the physician decided to remove the ruby coil and lantern together from the patient.Upon removal, it was noted that the lantern was stretched and possibly kinked at the distal end.The ruby coil was then removed from the lantern and was found to be stretched.Both devices were no longer used in the procedure.The procedure was completed using another lantern and additional ruby coils.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: 8659134
• Report Number: 3005168196-2019-01069
• Device Sequence Number: 2275306
• Product Code: HCG
• UDI-Device Identifier: 00814548019284
• UDI-Public: 00814548019284
• Combination Product (Y/N): Y
• Initial Reporter State: NC
• 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): 05/02/2019
• 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: 06/06/2026
• Device Catalogue Number: RBY2C2060
• Device Lot Number: F83909
• 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: 05/02/2019
• Initial Report FDA Received Date: 05/31/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 76 YR
• Date Report Sent to FDA: 01/01/2005