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

Model Number 24628

Device Problem Leak/Splash (1354)

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

Event Date 12/09/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that the balloon ruptured.A 6.00mm x 2.0cm x 50cm peripheral cutting balloon (pcb) was used in a shunt percutaneous transluminal angioplasty (pta) procedure.The target lesion was 75% stenosed with moderate tortuosity and mild calcification.The balloon was inflated for 30 second at 12atm during the second inflation.However, the balloon ruptured.The device was removed and the procedure was completed with another of the same device.There were no patient complications.

Event Description

It was reported that the balloon ruptured.A 6.00mm x 2.0cm x 50cm peripheral cutting balloon (pcb) was used in a shunt percutaneous transluminal angioplasty (pta) procedure.The target lesion was 75% stenosed with moderate tortuosity and mild calcification.The balloon was inflated for 30 second at 12atm during the second inflation.However, the balloon ruptured.The device was removed and the procedure was completed with another of the same device.There were no patient complications.

Manufacturer Narrative

E1: initial reporter address: (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 balloon was subjected to positive pressure.The returned device was attached to an encore inflation unit.Positive pressure was applied when liquid was observed to be leaking from a balloon pinhole leak approx.4mm distal from the proximal markerband.An examination of the markerbands identified no issues which could potentially have contributed to this complaint.The rated burst pressure (rbp) for this device is 10atm (1013 kpa).No issues were noted with the tip section of the device.A visual and microscopic examination found no issue with the markerbands.A visual and tactile examination identified no kinks or damage to the shaft of the returned device.

• 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 CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13155948
• MDR Text Key: 283254470
• Report Number: 2134265-2021-16249
• 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: 02/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/19/2023
• Device Model Number: 24628
• Device Catalogue Number: 24628
• Device Lot Number: 0027688451
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/31/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/19/2021
• 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