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

Catalog Number	RBY2C0312
Medical Device Problem Codes	Failure to Advance (2524); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/16/2019
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.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the gastroduodenal artery (gda) using ruby coils.During the procedure, the physician was unable to get around the corner to advance a lantern delivery microcatheter (lantern) into the gda using a 0.018 guidewire.Without having an alternative guidewire to improve the advancement of the lantern, the physician removed it, then advanced a non-penumbra microcatheter containing its own prepacked 0.021 guidewire into the target vessel.The physician then inserted a ruby coil introducer sheath into the rotating hemostasis valve (rhv), closed the rhv and watched the retrograde flush.When the flush was completed, the physician attempted to advance the ruby coil into the microcatheter; however, resistance was encountered and the ruby coil would not advance.The physician then removed the ruby coil and was able to advance the ruby coil out of its introducer sheath on the back table.The physician then re-inserted the ruby coil into the rhv; however, resistance was encountered again and the ruby coil would not advance into the microcatheter.After several failed attempts, the ruby coil was removed.The physician then removed the microcatheter being used, and re-advanced the lantern that was previously removed, into the gda.The procedure was completed using another ruby coil, a pod packing coil (podj) and the 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: 8345347
• Report Number: 3005168196-2019-00277
• Device Sequence Number: 16695257
• Product Code: HCG
• UDI-Device Identifier: 00814548012827
• UDI-Public: 00814548012827
• Combination Product (Y/N): Y
• Initial Reporter Country: GM
• PMA/510(K) Number: K120330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/16/2019
• 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: 08/29/2025
• Device Catalogue Number: RBY2C0312
• Device Lot Number: F78990
• 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: 01/16/2019
• Initial Report FDA Received Date: 02/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Weight: 75
• Date Report Sent to FDA: 01/01/2005