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

Model Number 24658

Device Problems Deflation Problem (1149); Inflation Problem (1310)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/29/2020

Event Type  malfunction  

Event Description

It was reported that balloon could not deflate.The 99% stenosed target lesion was located in the moderately tortuous and moderately calcified superficial femoral artery.A 4.00mm/ 1.5cm/ 140cm small peripheral cutting balloon was selected for use.During procedure, it was noted that the device failed to inflate and deflate.The procedure was completed with another of same device.No patient complications were reported.

Event Description

It was reported that balloon could not deflate.The 99% stenosed target lesion was located in the moderately tortuous and moderately calcified superficial femoral artery.A 4.00mm/ 1.5cm/ 140cm small peripheral cutting balloon was selected for use.During procedure, it was noted that the device failed to inflate and deflate.The procedure was completed with another of same device.No patient complications were reported.It was further reported that 4.00mm/ 1.5cm/ 140cm small peripheral cutting balloon inflated a little while inside the patient.The device was then removed.

Manufacturer Narrative

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.The device was attached to an encore inflation unit and the balloon was inflated to its rated burst pressure and no drop in pressure or leaks were noted.A vacuum was then applied, and the balloon deflated fully in 15 seconds.The balloon was inflated to its rated burst pressure and deflated on three more occasions with no leaks noted in the device.An examination of the balloon material identified no issues which could potentially have contributed to this complaint.A visual and microscopic examination identified no damage or issues with the markerbands or blades of the device that could have contributed to the complaint incident.All blades were present and fully bonded to the balloon material.A visual and microscopic examination identified no issues with the tip of the device that could have contributed to the complaint incident.A visual and tactile examination found the shaft of the device to be kinked at approximately 100mm proximal of the guidewire port.This type of damage is consistent with excessive force being applied to the device.

• 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: 11206799
• MDR Text Key: 227927969
• Report Number: 2134265-2021-00486
• Device Sequence Number: 1
• Product Code: NWX
• Combination Product (y/n): N
• 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: 02/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/13/2023
• Device Model Number: 24658
• Device Catalogue Number: 24658
• Device Lot Number: 0025355043
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2021
• Date Manufacturer Received: 01/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1