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

Catalog Number	RBY4C0835
Medical Device Problem Codes	Kinked (1339); Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/22/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of the pusher assembly.The pusher assembly was kinked approximately 6.0 and 8.0 cm from the proximal end of the pusher assembly.The embolization coil was intact with its pusher assembly.The embolization coil had offset coil winds.Conclusions: evaluation of the returned ruby coil confirmed the embolization coil was damaged.This type of damage likely occurred due to mishandling while retracting the coil.If the sheath were oriented such that the embolization coil did not have a smooth path of entry while retracting the device it may have contributed to the damage observed on the returned coil.These offset coil winds prevented the ruby coil from being re-sheathed during evaluation.Further evaluation of the returned ruby coil revealed pusher assembly was kinked.This damage was likely incidental to the reported failure and may have occurred during handling post-procedure or during packaging for return.The non-penumbra microcatheter identified in the complaint was not returned to penumbra for evaluation.The root cause of the ruby coil not forming could not be determined.Penumbra coils are visually inspected during in-process 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, the physician retracted and removed a ruby coil from the non-penumbra microcatheter because it was not forming as expected in the target location.The embolization coil then became kinked as the physician was retracting the ruby coil into its introducer sheath on the back table and, therefore, the ruby coil could not be fully re-sheathed.The procedure was completed using a new ruby 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: 7620774
• Report Number: 3005168196-2018-01204
• Device Sequence Number: 1590410
• Product Code: HCG
• UDI-Device Identifier: 00814548013206
• UDI-Public: 00814548013206
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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): 05/22/2018

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: 02/01/2025
• Device Catalogue Number: RBY4C0835
• Device Lot Number: F74223
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2018
• Initial Report FDA Received Date: 06/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 12 YR