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

Catalog Number	RBY2C2860
Medical Device Problem Codes	Bent (1059); Failure to Advance (2524); Physical Resistance (2578)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/07/2018
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: 3005168196-2018-00704, 3005168196-2018-00706, 3005168196-2018-00707.
Event or Problem Description
The patient was undergoing a coil embolization procedure to treat an abdominal aortic aneurysm endoleak (aaa endoleak) using ruby coils and a lantern delivery microcatheter (lantern).During the procedure, the physician placed a non-penumbra sheath and support catheter, then advanced a lantern through the catheter.While attempting to advance a ruby coil through the lantern, the physician experienced resistance and subsequently, the coil would not advance.Therefore, the ruby coil was re-sheathed and it was noted that the coil¿s pusher assembly was bent.The physician then decided to remove the lantern and upon removal, it was noticed that the lantern was kinked.A new lantern was then opened and the physician attempted to advance a new ruby coil through the lantern; however, tension and friction was encountered and subsequently, the ruby coil unintentionally detached in the lantern.Therefore, the physician attempted to remove the lantern containing the detached coil; however, while retracting the lantern, the coil came out of the lantern and became stuck inside the support catheter.Therefore, the physician removed the support catheter with the coil and decided to end the procedure at that point.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: 7399780
• Report Number: 3005168196-2018-00705
• Device Sequence Number: 16466738
• Product Code: HCG
• UDI-Device Identifier: 00814548013091
• UDI-Public: 00814548013091
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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
• Type of Report: Initial
• Report Date (Section B): 03/07/2018

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: 12/03/2025
• Device Catalogue Number: RBY2C2860
• Device Lot Number: F80851
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2018
• Initial Report FDA Received Date: 04/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 86 YR