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

Catalog Number	RBY4C0620
Medical Device Problem Codes	Detachment Of Device Component (1104); Physical Resistance (2578)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/26/2016
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 ruby coil was bent approximately 10.0, 26.0, and 108.0 cm from the proximal end of the pusher assembly.The ruby coil was kinked approximately 87.0 and 96.0 cm from the proximal end of the pusher assembly.The ruby coil was fractured approximately 42.0 and 94.0 cm from the hub.The ruby coil was received with the embolization coil detached half protruding from the introducer sheath.When trying to remove the embolization coil from the introducer sheath, the stretch resistant (sr) wire was fractured by the penumbra investigator.The embolization coil was damaged in multiple locations along its length.Conclusions: evaluation of the ruby coil revealed that the pusher assembly was bent, kinked, and fractured in multiple locations.The bends were likely incidental and likely occurred when packaging for return to penumbra.The kinks and fractures in the ruby coil were likely a result of repeated advancing or withdrawal of the embolization coil against resistance.If the pusher assembly becomes fractured, it may allow the pull wire to retract out of the distal detachment tip (ddt), which will in turn allow the embolization coil to detach.The embolization coil was severely damaged and wrapped around its proximal constraint sphere.Upon removing the coil from the introducer sheath, the sr wire was fractured due to the proximal constraint sphere being wrapped in coil windings.The sphere being trapped in the coil windings and numerous kinks along the embolization coil are likely a result of repeated attempts to advance or withdraw the coil after it had been unintentionally detached.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 advancing a ruby coil through another manufacturer's microcatheter, the technologist encountered resistance and subsequently, the coil unintentionally detached inside the microcatheter.Therefore, the microcatheter containing the detached ruby coil was removed and the procedure was completed using a new non-penumbra microcatheter and a new ruby coil.It should be noted that the physician did not use a rotating hemostasis valve (rhv) and did not maintain a continuous flush 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: 6064388
• Report Number: 3005168196-2016-01509
• Device Sequence Number: 441115
• Product Code: HCG
• UDI-Device Identifier: 00814548013183
• UDI-Public: 00814548013183
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/30/2016

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: Health Professional
• Device Expiration Date: 12/01/2023
• Device Catalogue Number: RBY4C0620
• Device Lot Number: F66759
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2016
• Initial Report FDA Received Date: 10/28/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1