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

Catalog Number	RBY4C0406
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	09/21/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the ruby coil was received with the pet lock intact on the pusher assembly.The embolization coil was intact with the pusher assembly.The embolization coil had offset coil windings in multiple locations.The pusher assembly was kinked approximately 9.0, 20.0, 43.0, 76.0, 97.0, and 113.0 cm from the proximal end of the pusher assembly.The introducer sheath was ovalized approximately 10.0 cm from the proximal end of the introducer sheath.The maximum outer diameter (od) of the embolization coil was measured and was found to be within specification.Conclusions: evaluation of the ruby coil revealed several kinks along the length of the pusher assembly.This damage may have occurred due to forceful manipulation of the ruby coil at extreme angles during insertion into a microcatheter, and likely contributed to the initial resistance felt by the physician.The embolization coil had multiple offset coil windings along its length.This damage may have occurred due to repeated manipulation of the ruby coil against resistance.Further evaluation revealed the introducer sheath was ovalized near the proximal end.The ruby coil was able to be cycled in and out of the introducer sheath without resistance.The non-penumbra microcatheter mentioned in the complaint was not returned for evaluation.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 gastroduodenal artery (gda) using ruby coils.During the procedure, while the physician was attempting to deploy a ruby coil into the gda using another manufacturer's microcatheter, the coil was unable to advance out of the end of the microcatheter.The physician made a few attempts to advance the ruby coil out of the microcatheter but encountered resistance.The physician stated that it felt like the coil "hit a wall".The ruby coil was then removed and the procedure was completed using gelfoam and the same non-penumbra microcatheter.It should be noted that the physician flushed the microcatheter in between each coil but did not use a rotating hemostasis valve (rhv) and did not maintain a continuous flush.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: 6038867
• Report Number: 3005168196-2016-01482
• Device Sequence Number: 889866
• Product Code: HCG
• UDI-Device Identifier: 00814548013169
• UDI-Public: 00814548013169
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 09/21/2016

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: 04/11/2024
• Device Catalogue Number: RBY4C0406
• Device Lot Number: F68909
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/21/2016
• Initial Report FDA Received Date: 10/19/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 58 YR