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

Model Number 24658

Device Problems Entrapment of Device (1212); Material Deformation (2976)

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

Event Date 02/25/2022

Event Type  malfunction  

Event Description

It was reported that the device was stuck with the guidewire.The target lesion was located in the moderately tortuous and severely calcified left superficial femoral artery.A 4.00mm/1.5cm/140cm small peripheral cutting balloon was selected for use.During the procedure, it was noted that the shaft got kinked and was stuck with a non boston scientific guidewire.The devices were removed as one unit.The procedure was completed with another of the same device.No patient complications were reported.

Manufacturer Narrative

Device evaluated by manufacturer: the device was returned for analysis.The device was received with the customers guidewire inserted in the device.The guidewire is noted to be damaged.A visual and tactile examination identified a complete break in the midshaft approximately 137mm proximal of the distal tip.The midshaft and hypotube was also noted to be kinked at several locations along its length.The midshaft was also noted to be accordined.This type of damage is consistent with excessive force being applied to the delivery system.A visual examination identified that the balloon was not subjected to positive pressure.An examination of the balloon identified no issues which could potentially have contributed to this complaint.A visual examination identified no damage to the tip, markerbands or blades of the device.All blades were present and fully bonded to the balloon material.This concludes the product analysis.

Event Description

It was reported that the device was stuck with the guidewire.The target lesion was located in the moderately tortuous and severely calcified left superficial femoral artery.A 4.00mm/1.5cm/140cm small peripheral cutting balloon was selected for use.During the procedure, it was noted that the shaft got kinked and was stuck with a non boston scientific guidewire.The devices were removed as one unit.The procedure was completed with another of the same device.No patient complications were reported.

• 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: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13865588
• MDR Text Key: 287817554
• Report Number: 2134265-2022-02902
• 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: 04/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2023
• Device Model Number: 24658
• Device Catalogue Number: 24658
• Device Lot Number: 0026261505
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/01/2022
• Initial Date FDA Received: 03/23/2022
• Supplement Dates Manufacturer Received: 03/30/2022
• Supplement Dates FDA Received: 04/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/28/2020
• 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
• Treatment: GUIDEWIRE - 0.014INCH JUPITER; GUIDEWIRE - 0.014INCH JUPITER