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

Catalog Number	RBY2C0415
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/20/2016
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 embolization coil was intact with the pusher assembly.The embolization coil had offset coil windings in multiple locations.During functional analysis, the ruby coil was able to be cycled in and out of its introducer sheath.Furthermore, the ruby coil was also able to be advanced through a demonstration px slim delivery microcatheter (px slim) without an issue.Conclusions: evaluation of the ruby coil revealed several offset coil windings along the length of the embolization coil.This type of damage typically occurs due to forceful advancement of the ruby coil against resistance.If a rotating hemostasis valve (rhv) is not used during insertion of the ruby coil into a microcatheter, the introducer sheath may not seat properly within the taper of the hub, and resistance may be experienced upon advancing the coil.Offset coil windings may further contribute to difficulty when attempting to advance the ruby coil.Further evaluation revealed the pusher assembly mid-joint was retracted proximal to the introducer sheath friction lock.The introducer sheath friction lock inner diameter (id) is smaller than the rest of the introducer sheath,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allows the introducer sheath to properly seat on the ruby coil mid-joint.If the pusher assembly mid-joint is forcefully withdrawn beyond the introducer sheath friction lock, it is likely that resistance will be experienced by the physician upon attempting to advance the ruby coil.Penumbra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 using ruby coils.During the procedure, while attempting to advance a ruby coil into another manufacturer's microcatheter, the physician was unable to advance the ruby coil out of its introducer sheath and into the hub of the microcatheter.The physician did not mention experiencing any resistance while attempting to advance the ruby coil out of its introducer sheath.The ruby coil was then removed and the procedure was completed using new ruby coils and the same non-penumbra microcatheter.It should be noted that the physician did not maintain a continuous flush but did flush the microcatheter in between each coil and used a rotating hemostasis valve (rhv) during the procedure.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: 6035641
• Report Number: 3005168196-2016-01475
• Device Sequence Number: 680095
• Product Code: HCG
• UDI-Device Identifier: 00814548012858
• UDI-Public: 00814548012858
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 09/20/2016

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: 07/31/2022
• Device Catalogue Number: RBY2C0415
• Device Lot Number: F44750
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/20/2016
• Initial Report FDA Received Date: 10/17/2016
• 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