MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION 2CM PERIPHERAL CUTTING BALLOON; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA

Model Number 24628

Device Problems Inflation Problem (1310); Leak/Splash (1354)

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

Event Date 11/26/2021

Event Type  malfunction  

Event Description

Reportable based on device analysis completed on 21dec2021.It was reported that a shaft leak occurred.The 90% stenosed target lesion was located in the moderately tortuous and mildly calcified cephalic vein.A 6.00mm/2.0cm/50cm peripheral cutting balloon was selected for use.During the procedure, the device was inserted after priming and was advanced into the lesion and then pressure applied.However, it was noted that the balloon did not inflate.The device was completely removed and it was noted that the contrast was leaking from the shaft.The procedure was complete with another of the same device.No patient complications were reported.However, device analysis revealed that the outer shaft of the device to be severely damaged and torn beginning approximately 250 mm from strain relief extending approximately 5mm distally along the shaft.

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.A microscopic examination found no damage or issues with the balloon material.The device could not be inflated due to severe damage to the shaft of the device.The rated burst pressure for this device is 10 atmospheres as per 2cm pcb specification.A visual and microscopic examination found no damage or issues with the blades of the device.All blades were intact and fully bonded to the balloon material.No issue was observed with the tip or markerbands of the device which could have contributed to the complaint incident.A visual and tactile examination found the outer shaft of the device to be severely damaged and torn beginning approximately 250 mm from strain relief extending approximately 5mm distally along the shaft.The returned device was attached to an encore inflation unit.Positive pressure was applied when liquid was observed to be leaking from the damaged section of the shaft.The inner guidewire lumen is undamaged.This type of damage could potentially have occurred due to an interaction with another device/object.This concludes the product analysis.

• Brand Name: 2CM PERIPHERAL CUTTING BALLOON
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA
• 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: 13231967
• MDR Text Key: 283787792
• Report Number: 2134265-2021-16349
• Device Sequence Number: 1
• Product Code: LIT
• 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: 01/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/29/2023
• Device Model Number: 24628
• Device Catalogue Number: 24628
• Device Lot Number: 0027578011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/21/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/29/2021
• 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