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

Model Number 24628

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 03/17/2022

Event Type  malfunction  

Manufacturer Narrative

Initial reporter city: (b)(6).

Event Description

It was reported that one of the blades peeled off from the balloon.The target lesion was located in the moderately tortuous shunt in the axilla.A 6.00mm/2.0cm/50cm peripheral cutting balloon was selected for use.During the procedure, the device was removed after dilatation was completed; however, the tip marker of the non-boston scientific sheath got caught in the blade.Consequently, the blade peeled off from the balloon, but the device was then removed completely.No patient complications were reported.

• 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: 14070367
• MDR Text Key: 289000276
• Report Number: 2134265-2022-03930
• 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: 04/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/22/2023
• Device Model Number: 24628
• Device Catalogue Number: 24628
• Device Lot Number: 0028066948
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/22/2021
• 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
• Treatment: MEDIKIT SUPER HIGH FLOW SHEATH