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

Model Number 24686

Device Problem Material Rupture (1546)

Patient Problem Pain (1994)

Event Date 01/17/2020

Event Type  Injury  

Manufacturer Narrative

Initial reporter facility name : (b)(6) hospital.

Event Description

It was reported that balloon rupture and patient pain occurred. The severely stenosed target lesion was located in the mildly calcified radio-cephalic internal fistula. A 6. 0 x40, 75cm gladiator elite balloon catheter was advanced through a guidewire under a colored ultrasound. However, during the slow first inflation at 18 atmospheres, the patient cried out for pain. The colored ultrasound showed the balloon did not inflate, but when the balloon was withdrawn, it was confirmed that the balloon had burst. The device was removed without any intervention. The procedure was completed with another of same device. There were no patient complications nor injuries reported and the patient status was stable.

• 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; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 9752067
• MDR Text Key: 180808972
• Report Number: 2134265-2020-02099
• Device Sequence Number: 1
• Product Code: LIT
• 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: company representative,distri

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 04/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 24686
• Device Catalogue Number: 24686
• Device Lot Number: 0024298977
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2020
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 03/27/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/21/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 02/25/2020 Patient Sequence Number: 1