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

Catalog Number	RBY2C2060
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/12/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of the pusher assembly.The embolization coil was intact with its pusher assembly.Prior to functionally testing the ruby coil, the pusher assembly was kinked by the penumbra investigator while loading a demonstration introducer sheath on the proximal end of the pusher assembly.After loading the introducer sheath on the pusher assembly, the ruby coil was advanced through a demonstration microcatheter and out of the distal tip without an issue.Conclusions: evaluation of the returned ruby coil revealed that the ruby coil was functional.During functional testing, a demonstration introducer sheath was loaded onto the ruby coil pusher assembly.Then the ruby coil was advanced through a demonstration microcatheter and out of the distal tip without an issue.The lantern identified in the complaint and the returned ruby coil introducer sheath were not returned to penumbra for evaluation.Therefore, the root cause of the resistance mentioned in the complaint could not be determined.Penumbra coils are visually inspected during in-process inspection and during quality inspection after manufacturing.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 ovarian vein using ruby coils.During the procedure, the physician successfully placed a ruby coil in the target vessel using a lantern delivery microcatheter (lantern).The physician then experienced resistance and was unable to advance another ruby coil out of its introducer sheath and into the lantern and, therefore, the ruby coil was removed.The procedure was then completed using a new ruby coil with 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: 8074154
• Report Number: 3005168196-2018-02249
• Device Sequence Number: 1913425
• Product Code: HCG
• UDI-Device Identifier: 00814548019284
• UDI-Public: 00814548019284
• Combination Product (Y/N): Y
• Initial Reporter State: MA
• 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): 10/16/2018
• 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: 06/18/2026
• Device Catalogue Number: RBY2C2060
• Device Lot Number: F84157
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2018
• 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: 10/16/2018
• Initial Report FDA Received Date: 11/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005