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

Model Number 24686

Device Problem Material Rupture (1546)

Patient Problems Inflammation (1932); Thrombosis (2100); Vasoconstriction (2126)

Event Date 04/09/2020

Event Type  Injury  

Event Description

It was reported that balloon rupture occurred and the patient experienced swelling, vasospasm, and thrombosis. The patient presented for a percutaneous balloon catheter dilatation. The stenosed, 1. 5mm, target lesion was located in the internal fistula of the left forearm. Blood flow of the internal fistula was less than 160ml/min. A 6. 0 x40, 40cm gladiator elite balloon catheter was advanced for dilation. During the procedure, the physician first raised the pressure to 24pascal (pa) for 30 seconds but the color doppler ultrasound showed that the stenosis was not dilated. The physician dilated a second time and the color doppler ultrasound showed the stenosis still existed. When the physician increased the pressure to 24pa during the third dilation, the balloon position in the patient's vessel suddenly gave out a loud abnormal sound and it was noted that the pressure gauge of the inflation device returned to zero. The balloon was withdrawn and when saline was injected into the balloon, it was noted that there was an approximately 5mm fracture in the middle section of the balloon material. The patient had a slight swelling in the internal fistula, vasospasm and thrombosis, so the procedure was immediately stopped. The planned procedure was cancelled because of the issue, and the patient will accept another selective operation. 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: 9991985
• MDR Text Key: 188979246
• Report Number: 2134265-2020-05179
• 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
• Report Date: 04/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2020
• 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: 0024314490
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 04/13/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/22/2019
• 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: 04/23/2020 Patient Sequence Number: 1