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

Model Number 24658

Device Problem Difficult to Remove (1528)

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

Event Date 08/15/2022

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr: the complaint device was received for product analysis with the balloon protector partially removed from the device.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 that may have potentially contributed to the complaint incident.All blades were fully bonded to the balloon material.A visual and tactile examination found the shaft polymer extrusion to be completely detached at the guidewire port.This type of damage is consistent with excessive tensile force being applied to the device.The shaft was also found to be severely kinked at approximately 50mm distal of the shaft separation location.The investigator was unable to apply a vacuum to the device as per preparation instructions indicated in spcb instructions for use due to the shaft break.For investigation purposes, the investigator removed the balloon protector with a little resistance experienced as negative pressure could not be applied to the device.The inner diameter of the balloon protector was verified using a calibrated pin gauge and was within specification.A visual investigation identified no damage or any issues with the markerbands of the device that could have contributed to the complaint incident.

Event Description

Reportable based on device analysis completed on 28sep2022.It was reported that the device did not come out of the sheath.A 4.00mmx1.5cmx140cm small peripheral cutting balloon was attempted to remove from the sheath as per normal procedure to use it for dialysis shunt stenosis.However, the device did not come out of the sheath at all.The treatment was completed with another of same device.This was a non-patient related event and had no impact on the patient.However, device analysis revealed that the shaft polymer extrusion was completely detached at the guidewire port.

• 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 ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15650363
• MDR Text Key: 307093620
• Report Number: 2124215-2022-41651
• 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
• Report Date: 10/21/2022

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: 11/21/2023
• Device Model Number: 24658
• Device Catalogue Number: 24658
• Device Lot Number: 0026400955
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/28/2022
• Initial Date FDA Received: 10/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/21/2020
• 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