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

Catalog Number	RBY2C0410-A
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	07/15/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the proximal end of the ruby coil hypotube was fractured, and the pull wire was completely withdrawn out of the pusher assembly.The pusher assembly was kinked in multiple locations.The embolization coil was detached from the pusher assembly.Conclusion: evaluation of the returned ruby coil revealed the embolization coil was detached from the pusher assembly, the proximal end of the pusher assembly hypotube was fractured, and the pull wire was completely withdrawn out of the pusher assembly.Since the ruby coil was reportedly removed from the procedure intact, this damage was likely incidental and likely occurred after removal from the procedure.Therefore, the root cause of the resistance experienced during advancement could not be determined.Further evaluation revealed the pusher assembly was kinked in multiple locations.This damage was likely incidental and may have occurred during packaging for return.The ruby coil embolization coil and the lantern mentioned in the complaint were not returned for evaluation.Penumbra coils and catheters 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 to treat a renal bleed using ruby coils.During the procedure, the physician deployed and detached five ruby coils in the target vessel using a lantern delivery microcatheter (lantern).While attempting to advance a new ruby coil through the lantern, the physician experienced resistance; therefore, it was removed intact.The procedure was then completed using three additional ruby coils and the same lantern.It should be noted that the physician did not use a rotating hemostasis valve (rhv) and did not use a continuous flush throughout 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: 6806039
• Report Number: 3005168196-2017-01398
• Device Sequence Number: 16607502
• Product Code: HCG
• UDI-Device Identifier: 00814548012841
• UDI-Public: 00814548012841
• 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): 07/24/2017

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: 01/01/2025
• Device Catalogue Number: RBY2C0410-A
• Device Lot Number: F73461
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2017
• Initial Report FDA Received Date: 08/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 45