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

Model Number 24658

Device Problem Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/13/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that the balloon ruptured.The 99% stenosed target lesion was located in the moderately tortuous and moderately calcified below the knee artery.A 3.50mm/ 1.5cm/ 140cm small peripheral cutting balloon was selected for use.During the procedure, it was noted that the balloon ruptured at 10 atmospheric pressure for 20 seconds upon first inflation.The procedure was completed with another of the same device.No complications reported.

Event Description

It was reported that the balloon ruptured.The 99% stenosed target lesion was located in the moderately tortuous and moderately calcified below the knee artery.A 3.50mm/ 1.5cm/ 140cm small peripheral cutting balloon was selected for use.During the procedure, it was noted that the balloon rupured at 10 atmospheric pressure for 20 seconds upon first inflation.The procedure was completed with another of the same device.No complications reported.

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.A microscopic examination identified a balloon longitudinal tear beginning at the centre of the distal markerband and extending approximately 10mm proximally.An examination of the balloon material and distal markerband identified no issues which could potentially have contributed to this complaint.The rated burst pressure for this device is 12 atmospheres.A visual and microscopic examination observed no damage to the tip or blades.All blades were present and fully bonded to the balloon surface.A visual and tactile examination found the hypotube of the device to be kinked at more than one location.This type of damage is consistent with excessive force being applied to the device.No issues were noted with the shaft polymer extrusion.

• 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: 9396373
• MDR Text Key: 174579624
• Report Number: 2134265-2019-14736
• 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: 01/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/10/2021
• Device Model Number: 24658
• Device Catalogue Number: 24658
• Device Lot Number: 0021975904
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2019
• Date Manufacturer Received: 01/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BALLOON CATHETER- SPCB; BALLOON CATHETER- SPCB; GUIDEWIRE-CRUISE; GUIDEWIRE-CRUISE; INTRODUCER SHEATH-MEDIKIT; INTRODUCER SHEATH-MEDIKIT