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 04/03/2023

Event Type  malfunction  

Event Description

It was reported that a balloon leak occurred.The 90% stenosed target lesion was located in the moderately tortuous and non calcified cephalic vein.A 6.00mm/2.0cm/50cm peripheral cutting balloon was selected for use.During the procedure, after flushing the non boston scientific guidewire lumen, this device was inserted through the 7f non boston scientific sheath to reach the lesion and pressurization was started, but the pressure did not rise at first inflation the balloon was removed and inflated outside the body; it was noted that the water was leaking from the base of the balloon.The procedure was completed with another of the same device.No patient complications were reported.

Manufacturer Narrative

Device evaluated by mfr: the device was returned for evaluation.A visual examination identified that the balloon was not folded which indicates that the device was subjected to positive pressure.The device was attached to an inflation device and positive pressure applied.Liquid was observed leaking from a pinhole located at the proximal edge of the proximal balloon bond.The balloon could not be inflated due to the pinhole in the balloon material.No other issues were identified with the balloon of the device.A visual examination found both markerbands undamaged and in the correct position on the device.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 identified no kinks or damage to the shaft of the device.No other issues were identified during the product analysis.

Event Description

It was reported that a balloon leak occurred.The 90% stenosed target lesion was located in the moderately tortuous and non calcified cephalic vein.A 6.00mm/2.0cm/50cm peripheral cutting balloon was selected for use.During the procedure, after flushing the non boston scientific guidewire lumen, this device was inserted through the 7f non boston scientific sheath to reach the lesion and pressurization was started, but the pressure did not rise at first inflation the balloon was removed and inflated outside the body; it was noted that the water was leaking from the base of the balloon.The procedure was completed with another of the same device.No patient complications were reported.

• Brand Name: 2CM PERIPHERAL CUTTING BALLOON
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• 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: 16812483
• MDR Text Key: 313984841
• Report Number: 2124215-2023-17745
• 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,Followup
• Report Date: 06/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 24628
• Device Catalogue Number: 24628
• Device Lot Number: 0030179321
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/20/2022
• 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