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

Model Number 24686

Device Problem Material Integrity Problem (2978)

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

Event Date 09/24/2021

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr. : a gladiator device was returned for analysis. A visual examination identified that the balloon was damaged and had detached from the shaft of the device. A circumferential tear was identified in the balloon material 15mm distal from the proximal balloon sleeve. A visual and microscopic examination observed that the tip was attached to the balloon section that detached from the balloon material. A visual and tactile examination found the inner balloon shaft had detached. There was also severe stretching noted on the inner balloon shaft. There were also multiple shaft kinks noted along the balloon inner shaft. An examination of the markerbands identified that both markerbands had moved on the shaft due to the severe shaft stretching.

Event Description

Reportable based on additional information received on 12-nov-2021. It was reported that balloon damage occurred. Vascular stenosis was located in the stoma site. A 6. 0 x40, 40cm gladiator balloon catheter was selected for use. During priming, the balloon was damaged. The procedure was completed with another of same device. There were no patient complications reported and the patient status was stable. However, it was further reported that the device was used inside the patient, balloon leak was noted during inflation, and shaft detachment was noted only after procedure.

• 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: 12917954
• MDR Text Key: 281665511
• Report Number: 2134265-2021-14732
• 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: Foreign,Health Professional,Company Representative,Distributor

Reporter Occupation

• Type of Report: Initial
• Report Date: 12/02/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 12/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 24686
• Device Catalogue Number: 24686
• Device Lot Number: 0025875109
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/12/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/18/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial