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

Catalog Number	RBY2C1240
Medical Device Problem Codes	Detachment Of Device Component (1104); Unraveled Material (1664)
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 not returned for evaluation.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.The device was implanted in the patient.
Event or Problem Description
The patient was undergoing a coil embolization procedure using ruby coils.During the procedure, the physician placed the initial coils in the target vessel using a lantern delivery microcatheter (lantern).While attempting to deploy a ruby coil in the target vessel, the lantern backed up in the non-penumbra sheath and consequently, the ruby coil became tangled between the lantern and the sheath.Subsequently, the ruby coil unintentionally detached, with the left part of the ruby coil running down the left side of the gonadal vein.Therefore, the physician tried bringing a long sheath to the coil mass and push the rest of the ruby coil with a coil pusher and two balloons.However, the ruby coil became unraveled and remained in the patient's body.The procedure was ended at that point and there was no 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: 7448810
• Report Number: 3005168196-2018-00819
• Device Sequence Number: 2053643
• Product Code: HCG
• UDI-Device Identifier: 00814548013015
• UDI-Public: 00814548013015
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K120330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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: 06/25/2025
• Device Catalogue Number: RBY2C1240
• Device Lot Number: F77901
• 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: 04/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 55 YR