MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION GLADIATOR ELITE; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number 24686

Device Problem Material Rupture (1546)

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

Event Date 05/08/2022

Event Type  malfunction  

Event Description

It was reported that balloon rupture occurred.The stenosed target lesion was located in an internal fistula of the cephalic arch.A 6.0 x40, 75cm gladiator elite balloon catheter was advanced for dilatation.However, during the procedure, the balloon ruptured in cross-section inside the patient after dilated at 18 atmospheres.The procedure was completed with another of same device.No patient complications nor injuries were reported and the patient status was stable.

Event Description

It was reported that balloon rupture occurred.The stenosed target lesion was located in an internal fistula of the cephalic arch.A 6.0 x40, 75cm gladiator elite balloon catheter was advanced for dilatation.However, during the procedure, the balloon ruptured in cross-section inside the patient after dilated at 18 atmospheres.The procedure was completed with another of same device.No patient complications nor injuries were reported and the patient status was stable.It was further reported that the balloon ruptured during the first inflation for 18 seconds and no balloon segment detach inside the patient.

• Brand Name: GLADIATOR ELITE
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; pmt 741 persiaran cassia selat; bandarcassia, pulau pinan 14110 ; MY 14110
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 14430909
• MDR Text Key: 291966022
• Report Number: 2134265-2022-05646
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 08714729809739
• UDI-Public: 08714729809739
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K132810
• 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: 05/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2024
• Device Model Number: 24686
• Device Catalogue Number: 24686
• Device Lot Number: 0027942938
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/12/2022
• Initial Date FDA Received: 05/18/2022
• Supplement Dates Manufacturer Received: 05/18/2022
• Supplement Dates FDA Received: 05/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2021
• 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
• Patient Age: 56 YR
• Patient Sex: Male
• Patient Weight: 73 KG