MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RUBICON 35; CATHETER, PERCUTANEOUS

Model Number 39540

Device Problem Material Perforation (2205)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/23/2020

Event Type  malfunction  

Event Description

It was reported that a catheter perforation occurred.The target lesion was located in the moderately tortuous and moderately calcified right iliac arterial stent and left angiogram.A 90cm rubicon 18 guide catheter was selected for use.During the procedure, after removal of the device from the patient's body, it was discovered that the wire inside the catheter penetrated through the rubicon catheter.The wire was visibly out of the catheter.The procedure was completed using multiple catheters of various types.No complications were reported and the patient was fine post procedure.

Event Description

It was reported that a catheter perforation occurred.The target lesion was located in the moderately tortuous and moderately calcified right iliac arterial stent and left angiogram.A 90cm rubicon 18 guide catheter was selected for use.During the procedure, after removal of the device from the patient's body, it was discovered that the wire inside the catheter penetrated through the rubicon catheter.The wire was visibly out of the catheter.The procedure was completed using multiple catheters of various types.No complications were reported and the patient was fine post procedure.It was further reported that a 90cm rubicon 35 guide catheter was selected for use.

Manufacturer Narrative

Device evaluated by mfr: the device was returned for analysis.There was blood and contrast in the device.Analysis of the tip, shaft, and hub relief included microscopic and visual inspection.Inspection revealed a shaft kink located 5.9cm from the tip, and shaft damage (hole/perforation) located 10.2cm from the tip.Inspection of the rest of the device found no other damage or defect.The reported shaft perforation was confirmed.

Event Description

It was reported that a catheter perforation occurred.The target lesion was located in the moderately tortuous and moderately calcified right iliac arterial stent and left angiogram.A 90cm rubicon 18 guide catheter was selected for use.During the procedure, after removal of the device from the patient's body, it was discovered that the wire inside the catheter penetrated through the rubicon catheter.The wire was visibly out of the catheter.The procedure was completed using multiple catheters of various types.No complications were reported and the patient was fine post procedure.It was further reported that a 90cm rubicon 35 guide catheter was selected for use.

• Brand Name: RUBICON 35
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10942043
• MDR Text Key: 219506096
• Report Number: 2134265-2020-16851
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• PMA/PMN Number: K122394
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 01/19/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 08/07/2023
• Device Model Number: 39540
• Device Catalogue Number: 39540
• Device Lot Number: 0025830027
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2020
• Initial Date Manufacturer Received: 11/24/2020
• Initial Date FDA Received: 12/03/2020
• Supplement Dates Manufacturer Received: 12/04/2020; 01/14/2021
• Supplement Dates FDA Received: 12/14/2020; 01/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1