MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RUBICON 18; CATHETER, PERCUTANEOUS

Model Number	39540
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/08/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.Visual examination of the device showed damage in the form of stretching, kinks and a separation.The separated component that was not returned is approximately 12cm long.This device should measure 150cm long and the returned shaft measure 138cm long.The separation was 12cm from the tip.The returned portion showed 3 kinks located 24cm, 63cm and 102.5cm from the hub.There was stretching of the device located 132.5cm to 134cm from the hub.A.018 test guidewire was inserted into the catheter shaft through the hub end.The guidewire transcended through the shaft until the stretched area where the guidewire stopped.Inspection of the remainder of the device apart from the observed damage, revealed no other damage or irregularities.
Event or Problem Description
Reportable based on device analysis completed on 21jan2020.It was reported that a guidewire and catheter entrapment occurred.The target lesion was located in the right posterior tibial artery.A rubicon was selected for use over a v18 guidewire.During attempts to cross the lesion, the rubicon and v18 guidewire became entrapped with each other.The v18 guidewire could not be removed from the rubicon and the devices were removed together as one unit.The procedure was completed with another of the same device.No complications reported and the patient was stable post procedure.However, device analysis revealed separation at 12cm from the tip.

• Brand Name: RUBICON 18
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9700262
• Report Number: 2134265-2020-01316
• Device Sequence Number: 11287870
• Product Code: DQY
• UDI-Device Identifier: 08714729829256
• UDI-Public: 08714729829256
• Combination Product (Y/N): N
• Initial Reporter Country: EG
• PMA/510(K) Number: K122394
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/12/2020

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: Health Professional
• Device Expiration Date: 03/07/2022
• Device Model Number: 39540
• Device Catalogue Number: 39540
• Device Lot Number: 0023458671
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/21/2020
• Initial Report FDA Received Date: 02/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 50 YR