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

Model Number 24658

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/06/2023

Event Type  malfunction  

Event Description

It was reported that a balloon separation occurred.The 90% stenosed target lesion was located in the moderately tortuous and mildly calcified superficial femoral artery.A 4.00mm/1.5cm/140cm small peripheral cutting balloon was selected for use.During preparation, outside the patient, it was noted that the catheter and balloon separated during removal of the protective sleeve from the balloon.The procedure was completed with a different device.No patient complications were reported.

Event Description

It was reported that a balloon separation occurred.The 90% stenosed target lesion was located in the moderately tortuous and mildly calcified superficial femoral artery.A 4.00mm/1.5cm/140cm small peripheral cutting balloon was selected for use.During preparation, outside the patient, it was noted that the catheter and balloon separated during removal of the protective sleeve from the balloon.The procedure was completed with a different device.No patient complications were reported.

Manufacturer Narrative

Device evaluated by mfr: the device was returned for evaluation.The device was received in two sections due to a detachment of the shaft.The balloon protector was not returned for analysis.The device was returned with the balloon protector fully removed from the device.The balloon protector was not returned for analysis.A visual examination identified that the balloon was not subjected to positive pressure.The balloon material and blades of the device were visually examined, and no issues were noted.All blades were fully bonded to the balloon material.A visual and tactile examination found the shaft polymer extrusion to be completely separated at the guidewire port.This type of damage is consistent with excessive tensile force being applied to the device.A visual investigation identified no damage or any issues with the markerbands of the device that could have contributed to the complaint incident.No other issues were identified during the product analysis.

• 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
• Manufacturer (Section G): BOSTON SCIENTIFIC IRELAND LIMITED; ballybrit business park; galway ; EI
• Manufacturer Contact: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16612352
• MDR Text Key: 312321596
• Report Number: 2124215-2023-12697
• Device Sequence Number: 1
• Product Code: NWX
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/10/2023
• Device Model Number: 24658
• Device Catalogue Number: 24658
• Device Lot Number: 0026333296
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/10/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1