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

Model Number 24658

Device Problems Inflation Problem (1310); Material Rupture (1546)

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

Event Date 09/29/2022

Event Type  malfunction  

Event Description

It was reported that a balloon rupture occurred.A 4.00mm/1.5cm/140cm small peripheral cutting balloon was selected for use.During the procedure, an attempt was made to deliver the balloon to the lesion for dilation, but the pressure did not increase, the balloon was ruptured and the sheath could not be used.The device was removed without any problem and the procedure was completed with another of the same device.No complications reported and the patient is in good condition after the procedure.

Manufacturer Narrative

Initial reporter city: (b)(6).

Manufacturer Narrative

E1.Initial reporter city-matsubara city osaka pref.(b)(6).Device evaluated by manufacturer: the device was returned for analysis.A visual examination identified that the balloon was not folded which indicates that the device was subjected to positive pressure.Blood was identified within the balloon which is evidence of a device leak.A balloon pinhole was identified at approximately 7mm proximal of the distal marker band.An examination of the balloon material and marker bands identified no issues which could potentially have contributed to this complain.The rated burst pressure for this device is 12 atmospheres as per spcb flextome specification.A visual examination observed no damage to the tip or blades.All blades were present and fully bonded to the balloon surface.A visual and tactile examination found the hypotube to be kinked at more than one location along its length.This type of damage is consistent with excessive force being applied to the delivery system.

Event Description

It was reported that a balloon rupture occurred.A 4.00mm/1.5cm/140cm small peripheral cutting balloon was selected for use.During the procedure, an attempt was made to deliver the balloon to the lesion for dilation, but the pressure did not increase, the balloon was ruptured and the sheath could not be used.The device was removed without any problem and the procedure was completed with another of the same device.No complications reported and the patient is in good condition after the procedure.

• 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: 15624792
• MDR Text Key: 301917001
• Report Number: 2124215-2022-41905
• 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: 10/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2022
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/27/2022
• 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