MAUDE Adverse Event Report: COVIDIEN LP EVERCROSS; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number AB35W07080080

Device Problem Material Rupture (1546)

Patient Problem Insufficient Information (4580)

Event Date 02/15/2021

Event Type  malfunction  

Event Description

The distensible balloon of the evercross¿ otw pta balloon catheter burst while being inflated by the interventional radiology (ir) md.Ir md removed the balloon.

• Brand Name: EVERCROSS
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): COVIDIEN LP; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 11472676
• MDR Text Key: 239414075
• Report Number: 11472676
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AB35W07080080
• Device Catalogue Number: AB35W07080080
• Device Lot Number: A892079
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/26/2021
• Device Age: 18 MO
• Event Location: Hospital
• Date Report to Manufacturer: 03/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 12410 DA
• Patient Weight: 73