MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION MAVERICK; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

Model Number 7585

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/21/2020

Event Type  malfunction  

Manufacturer Narrative

Age at the time of event: 18 years or older.

Event Description

It was reported that catheter entrapment and shaft break occurred.The target lesion was located in the left anterior descending artery.A 1.50mm x 15mm maverick balloon catheter was advanced for dilatation.However, the device became stuck with the non-bsc guide wire and while exerting extra pressure to pull back the balloon, the shaft broke into two parts.No patient complications were reported and the patient was stable.

Event Description

It was reported that shaft break and froze on wire occurred.The target lesion was located in the left anterior descending artery.A 1.50mm x 15mm maverick 2 balloon catheter was advanced for dilation.However, during dilation, the balloon was stuck in the guidewire.While using extra pressure pulling back the balloon, the shaft broke.There were no patient complications reported.

Manufacturer Narrative

Age at the time of event: 18 years or older.Device evaluated by mfr.: returned product consisted of a maverick 2 balloon catheter.The shaft, hypotube, tip and balloon were microscopically and visually examined.There were numerous kinks.There was blood in the guidewire lumen.The balloon was loosely folded.There was a complete separation 108.4cm from the strain relief.The shaft was stretched down proximally of the exit notch.The shaft was stretched down starting 2mm distal of the exit notch for 5mm.The shaft was buckled 16.5cm from the tip.The inner shaft was buckled 4mm from the tip.A section of the shaft was missing between the exit notch and the shaft separation near the hypotube bond.The length could not be determined due to the stretched shaft damage.Inspection of the remainder of the device presented no other damage or irregularities.

• Brand Name: MAVERICK
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10093151
• MDR Text Key: 192254378
• Report Number: 2134265-2020-06078
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08714729370055
• UDI-Public: 08714729370055
• Combination Product (y/n): N
• PMA/PMN Number: P860019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 08/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/08/2022
• Device Model Number: 7585
• Device Catalogue Number: 7585
• Device Lot Number: 0024240697
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2020
• Date Manufacturer Received: 08/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: GUIDE WIRE: BMW; GUIDE WIRE: BMW; GUIDE WIRE: BMW