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

Catalog Number	RBY2C0420
Medical Device Problem Codes	Failure to Advance (2524); Physical Resistance (2578)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/02/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of the ruby coil pusher assembly.The pusher assembly was bent in multiple locations along its length.The pusher assembly mid-joint was retracted proximal to the introducer sheath friction lock.The embolization coil was intact with the pusher assembly.Conclusions: evaluation of the returned device revealed the pusher assembly mid-joint was retracted proximal to the introducer sheath friction lock.The friction lock inner diameter (id) is smaller than the rest of the introducer sheath, which allows the introducer sheath to properly seat on the ruby coil mid-joint.If the pusher assembly mid-joint is forcefully withdrawn beyond the introducer sheath friction lock, it is likely that resistance will be experienced by the physician upon attempting to advance the ruby coil.Further evaluation revealed the pusher assembly was bent.This damage was likely incidental and may have occurred during packaging for return to penumbra.Penumbra coils are 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 portal veins using ruby coils.During the procedure, the physician successfully placed some ruby coils, pod coils, other manufacturers'' coils and vascular plugs into the portal veins.While attempting to advance a new ruby coil through the other manufacturer's microcatheter, the physician encountered resistance and was unable to advance the coil.Therefore, the ruby coil and its introducer sheath were removed from the hub of the microcatheter.The physician then attempted to advance the ruby coil onto the table and noticed that the coil would not advance out of its introducer sheath.Thereafter, the procedure was successfully completed using new ruby coils, pod coils, other manufacturers' coils and vascular plugs.It should be noted that the physician did not maintain a continuous flush through the rotating hemostasis valve (rhv) but did flush the microcatheter in between each coil.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: 6140425
• Report Number: 3005168196-2016-01754
• Device Sequence Number: 153696
• Product Code: HCG
• UDI-Device Identifier: 00814548012865
• UDI-Public: 00814548012865
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K120330
• 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): 11/02/2016

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: Physician
• Device Expiration Date: 04/30/2022
• Device Catalogue Number: RBY2C0420
• Device Lot Number: F42598
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/02/2016
• Initial Report FDA Received Date: 12/01/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 42 YR