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

Model Number 24686

Device Problems Break (1069); Deflation Problem (1149)

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

Event Date 02/24/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: used the first date of the month of the aware date as no event date was provided.

Event Description

It was reported that shaft break and balloon deflation failure occurred.A 8.0 x80, 75cm gladiator elite balloon catheter was advanced for dilatation.However, the balloon was difficult to deflate, so the physician removed both the balloon and the sheath.Upon removal, the shaft was broken.The procedure was completed with another of same device.No patient complications were reported.

Manufacturer Narrative

Device evaluated by mfr.: a gladiator 8 x 80, 20am, 75cm, was returned for analysis.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.The device was attached to an encore inflation unit and the balloon was inflated to its rated burst pressure using inflation media glycerol/water and no leaks were noted.A vacuum was then applied, and the balloon deflated fully in 09 seconds.The deflation time was verified using digital timer.The balloon was inflated to its rated burst pressure and deflated on three more occasions with no leaks noted in the device.The times were measured at 10, 09, 08 seconds.The inflation device was verified at 20 atmospheres before and after use with a calibrated pressure gauge.An examination of the balloon material identified no issues which could potentially have contributed to this complaint.A visual and microscopic examination observed no damage to the tip of the device.A visual and tactile examination identified that the shaft had been damaged beginning approximately 3mm proximal of the proximal balloon bond and extending approximately 4mm proximally.This type of damage is consistent with excessive tensile force being applied to the device.A visual examination found no issues or damage to the markerbands of the device.No other issues were identified during the product analysis.

Event Description

It was reported that shaft break and balloon deflation failure occurred.A 8.0 x80, 75cm gladiator elite balloon catheter was advanced for dilatation.However, the balloon was difficult to deflate, so the physician removed both the balloon and the sheath.Upon removal, the shaft was broken.The procedure was completed with another of same device.No patient complications were reported.

• 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: 11474388
• MDR Text Key: 239473702
• Report Number: 2134265-2021-02583
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 08714729809913
• UDI-Public: 08714729809913
• 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,health
• Type of Report: Initial,Followup
• Report Date: 04/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/18/2023
• Device Model Number: 24686
• Device Catalogue Number: 24686
• Device Lot Number: 0026381172
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2021
• Date Manufacturer Received: 03/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 83 YR