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

Model Number	39540
Medical Device Problem Codes	Entrapment of Device (1212); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/15/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a the tip of the catheter was broken.A 135cm rubicon18 guide catheter was selected for use.During procedure, when removing the device, it was noted that the catheter could not be withdrawn when it had already crossed the lesion along with v18 guidewire.It was further noted that the rubicon catheter was glued together with the wire.The physician could not separate them even outside the patient and when he tried with all his force to do that, it was noted that the tip of catheter was fractured on the guidewire.The procedure was completed with a different device.No patient complications were reported and the patient's status was stable.
Event or Problem Description
It was reported that a the tip of the catheter was broken.A 135cm rubicon18 guide catheter was selected for use.During procedure, when removing the device, it was noted that the catheter could not be withdrawn when it had already crossed the lesion along with v18 guidewire.It was further noted that the rubicon catheter was glued together with the wire.The physician could not separate them even outside the patient and when he tried with all his force to do that, it was noted that the tip of catheter was fractured on the guidewire.The procedure was completed with a different device.No patient complications were reported and the patient's status was stable.
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned for analysis.Returned device consisted of a rubicon 18 with an v-18 guidewire stuck in the device.The device was visually inspected for any damage.The catheter showed the guidewire stuck in the device.It was noticed that severe buckling had occurred from the tip to proximally 23cm.With the buckling that was noticed constriction of the shaft on the guidewire is consistent with guidewire sticking issues.It was noticed that the hub was detached from the shaft and not returned with the device.Inspection of the shaft revealed that tip detachment was not confirmed; however, the tip was damaged with a slight cut.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.

• 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: 8160241
• Report Number: 2134265-2018-63937
• Device Sequence Number: 2370576
• Product Code: DQY
• UDI-Device Identifier: 08714729829249
• UDI-Public: 08714729829249
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K122394
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2019

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: 03/02/2021
• Device Model Number: 39540
• Device Catalogue Number: 39540
• Device Lot Number: 0021814568
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2019
• Initial Date Received by Manufacturer: 11/26/2018
• Supplement Date Received by Manufacturer: 01/30/2019
• Initial Report FDA Received Date: 12/13/2018
• Supplement Report FDA Received Date: 02/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Weight: 55