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the patient cried out for pain.The colored ultrasound showed the balloon did not inflate, but when the balloon was withdrawn, it was confirmed that the balloon had burst.The device was removed without any intervention.The procedure was completed with another of same device.There were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.

Manufacturer Narrative

E1: initial reporter facility name - (b)(6).Device evaluated by mfr.: 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.Blood was identified within the balloon and inflation lumen which is evidence of a device leak.A visual and microscopic examination identified a balloon longitudinal tear beginning approximately 8mm proximal of the proximal markerband and extending approximately 54mm distally across the balloon material.An examination of the balloon material and markerbands identified no issues which could potentially have contributed to this complaint.A visual and microscopic examination of the markerbands identified no issues which may potentially have contributed to the complaint incident.A visual and tactile examination found no kinks or damage to the shaft of the returned device.A visual and tactile examination identified no damage to the tip which may have potentially contributed to the complaint incident.No issues were identified during the product analysis.

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
• MDR Report Key: 9752067
• MDR Text Key: 180808972
• Report Number: 2134265-2020-02099
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 08714729809739
• UDI-Public: 08714729809739
• Combination Product (y/n): N
• PMA/PMN Number: K132810
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 04/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/20/2022
• 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
• Initial Date Manufacturer Received: 02/12/2020
• Initial Date FDA Received: 02/25/2020
• Supplement Dates Manufacturer Received: 03/27/2020
• Supplement Dates FDA Received: 04/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 39 YR
• Patient Weight: 55