MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SMALL PERIPHERAL CUTTING BALLOON; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

Model Number 24658

Device Problems Inflation Problem (1310); Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/14/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that a balloon rupture occurred.An antegrade approach was performed via the ipsilateral femoral artery towards the 99% stenosed target lesion area in a moderately tortuous and moderately calcified left anterior artery.A 3.00mm/1.5cm/140cm small peripheral cutting balloon was selected for use.During the procedure, after the guidewire was passed through, it was noted that the device was advanced, but there was no increase in the pressure.When negative pressure was applied, blood was drawn, and it was found that the balloon ruptured upon the first inflation.After that, the lesion was successfully dilated by a coyote balloon dilatation catheter.The device was simply removed from the patient's body and the procedure was completed with a different device.No complications reported and the patient's condition was good post procedure.

Manufacturer Narrative

E1.Initial reporter city: (b)(6).Device evaluated by manufacturer: the device was returned for analysis.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.Blood was identified in the balloon which is indicative of a leak.No tears or holes were visible in the balloon.The device was attached to an encore inflation device and positive pressure was applied.A pinhole leak was identified 4mm distal of the proximal markerband.An examination of the balloon material and markerbands identified no issues which could potentially have contributed to this complaint.All blades were fully bonded onto the balloon with no issues identified.No issues were noted with the tip section of the device.A visual and microscopic examination found no issue with the markerbands.A visual and tactile examination found no issues with the hypotube.No other issues were identified during the product analysis.

Event Description

It was reported that a balloon rupture occurred.An antegrade approach was performed via the ipsilateral femoral artery towards the 99% stenosed target lesion area in a moderately tortuous and moderately calcified left anterior artery.A 3.00mm/1.5cm/140cm small peripheral cutting balloon was selected for use.During the procedure, after the guidewire was passed through, it was noted that the devcie was advanced, but there was no increase in the pressure.When negative pressure was applied, blood was drawn, and it was found that the balloon ruptured upon the first inflation.After that, the lesion was successfully dilated by a coyote balloon dilatation catheter.The device was simply removed from the patient's body and the procedure was completed with a different device.No complications reported and the patient's condition was good post procedure.

• Brand Name: SMALL PERIPHERAL CUTTING BALLOON
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9829018
• MDR Text Key: 183322951
• Report Number: 2134265-2020-02469
• Device Sequence Number: 1
• Product Code: NWX
• Combination Product (y/n): N
• PMA/PMN Number: P950020
• 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: 04/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/02/2022
• Device Model Number: 24658
• Device Catalogue Number: 24658
• Device Lot Number: 0023736662
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2020
• Date Manufacturer Received: 03/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: COYOTE- BALLOON DILATATION CATHETER; COYOTE- BALLOON DILATATION CATHETER; COYOTE- BALLOON DILATATION CATHETER