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

Catalog Number	RBY4C0406
Medical Device Problem Code	Physical Resistance (2578)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/18/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the ruby coil was kinked approximately 5.0 cm from its proximal end and bent along its length.The embolization coil was intact with the pusher.Conclusions: evaluation of the returned ruby coil revealed it was able to be advanced and retracted through a demonstration catheter without issue.Initially, the device was unable to move in its sheath.This was likely due to contrast hardening and causing the polymer section of the pusher assembly to become stuck to the inside of the introducer sheath.This is likely not the cause of the difficulty advancing experienced during the procedure.During functional analysis, the device was able to be advanced through its sheath and a demonstration catheter without issue.Therefore, the root cause of the difficulty advancing could not be determined.Further evaluation revealed bends and a kink on the pusher assembly.This damage was likely incidental and may have been a result of the returned packaging condition.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 to treat a gastrointestinal bleeding (gi bleed) using ruby coils.During the procedure, while attempting to load a ruby coil into a non-penumbra microcatheter, the physician experienced resistance in the proximal part of the microcatheter; therefore, the ruby coil was removed.It was also reported that resistance was encountered when removing the ruby coil.The procedure was completed using another ruby coil and the same microcatheter.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: 7419901
• Report Number: 3005168196-2018-00748
• Device Sequence Number: 48745
• Product Code: HCG
• UDI-Device Identifier: 00814548013169
• UDI-Public: 00814548013169
• Combination Product (Y/N): N
• Initial Reporter State: ID
• 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): 03/19/2018

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: 09/11/2025
• Device Catalogue Number: RBY4C0406
• Device Lot Number: F79485
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/19/2018
• Initial Report FDA Received Date: 04/10/2018
• 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