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

Catalog Number	RBY4C0620
Medical Device Problem Codes	Retraction Problem (1536); Failure to Advance (2524); Physical Resistance (2578)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/03/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the hypogastric artery using ruby coils.During the procedure, the physician made two attempts to advance a ruby coil out of a lantern delivery microcatheter (lantern); however, resistance was encountered and subsequently, the ruby coil would not advance.While attempting to reposition the ruby coil inside the lantern, the ruby coil became stuck and would not retract; therefore, the physician pulled it out intact.The procedure was completed using additional ruby coils and the same lantern.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
The pet lock was intact on the proximal end of the pusher assembly, and the pusher assembly was fractured approximately 5.0 cm from the proximal end.The pusher assembly was kinked approximately 55.0 cm from the proximal end.The introducer sheath was re-loaded backward on the pusher assembly.The embolization coil was intact with the pusher assembly.Evaluation of the returned device revealed the pusher assembly was kinked and fractured.This damage was likely incidental and may have occurred during packaging for return to penumbra.If the pusher assembly becomes fractured, it may allow the pull wire to withdraw out of the distal detachment tip (ddt), which will allow the embolization coil to detach.When a penumbra investigator attempted to remove the backwards-loaded introducer sheath and re-sheath the ruby coil, the pull wire became withdrawn, and the embolization coil became detached.Due to the returned condition of the ruby coil and the detachment of the embolization coil during functional testing, the root cause of the reported resistance could not be determined.The lantern mentioned in the complaint was 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.

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 6990596
• Report Number: 3005168196-2017-01899
• Device Sequence Number: 10892404
• Product Code: HCG
• UDI-Device Identifier: 00814548013183
• UDI-Public: 00814548013183
• 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,Followup
• Report Date (Section B): 10/03/2017

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: 01/11/2025
• Device Catalogue Number: RBY4C0620
• Device Lot Number: F73788
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2017
• Initial Date Received by Manufacturer: 10/03/2017
• Supplement Date Received by Manufacturer: 11/17/2017
• Initial Report FDA Received Date: 10/31/2017
• Supplement Report FDA Received Date: 05/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 57 YR