MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RUNWAY CLS4 6F; CATHETER, PERCUTANEOUS

Model Number 08714729478393

Device Problems Break (1069); Difficult to Remove (1528); Material Deformation (2976)

Patient Problem Tissue Damage (2104)

Event Date 07/08/2020

Event Type  Injury  

Event Description

Cardiac catheter broke off while in patient during procedure.Hub of catheter broke and catheter had significant kinks.Catheter was unable to be retrieved in cardiovascular lab.Pt transferred to hospital with vascular surgery capabilities.Femoral artery cutdown and catheter retrieval completed without further incident.Fda safety report id# (b)(4).

• Brand Name: RUNWAY CLS4 6F
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION ; tijuana baja CA 22444
• MDR Report Key: 10282822
• MDR Text Key: 199302976
• Report Number: MW5095549
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/13/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 02/06/2023
• Device Model Number: 08714729478393
• Device Catalogue Number: H7493389695750
• Device Lot Number: 60225922
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/15/2020
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR
• Patient Weight: 111