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

Catalog Number	RBY2C2457
Medical Device Problem Codes	Inadequacy of Device Shape and/or Size (1583); Failure to Advance (2524); Physical Resistance (2578)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/26/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was disposed of by the hospital and is no longer available for return.Without the return of the device, the root cause of the problem cannot be determined.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.This report is associated with mfr report numbers: 3005168196-2018-00838, 3005168196-2018-00840.
Event or Problem Description
The patient was undergoing a coil embolization procedure using pod packing coils (podjs) and ruby coils.During the procedure, the physician was unable to fully advance a podj and a ruby coil out of the distal tip of a lantern delivery microcatheter (lantern) because the coils were too large.The physician therefore removed the podj and the ruby coil and placed them on the back table.Later in the procedure, the physician attempted to reuse the podj and ruby coil, however was unable to advance the coils out of their introducer sheaths and into the lantern.The physician attempted to place another podj, however lost access with the lantern and diagnostic catheter, causing the podj to break in half.The physician attempted to remove the podj; however, the sr wire inside the podj then snapped in half, and the podj unraveled.The physician attempted to pull out the podj by pulling the sr wire, however, was unable to remove the embolization coil.The physician, therefore, cut the sr wire of the podj and pushed the embolization coil into the target location.The embolization part of the procedure ended at this point.There was no alleged deficiency against the lantern and 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: 7454765
• Report Number: 3005168196-2018-00839
• Device Sequence Number: 1083520
• Product Code: HCG
• UDI-Device Identifier: 00814548013084
• UDI-Public: 00814548013084
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 03/26/2018

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: 07/23/2025
• Device Catalogue Number: RBY2C2457
• Device Lot Number: F78340
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/26/2018
• Initial Report FDA Received Date: 04/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 16 YR