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

Model Number	24686
Medical Device Problem Codes	Break (1069); Deflation Problem (1149)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: used the first date of the month of the aware date as no event date was provided.
Event or Problem 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.
Additional 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 or Problem 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
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11474388
• Report Number: 2134265-2021-02583
• Device Sequence Number: 3876693
• Product Code: LIT
• UDI-Device Identifier: 08714729809913
• UDI-Public: 08714729809913
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K132810
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Initial Date Received by Manufacturer: 02/24/2021
• Supplement Date Received by Manufacturer: 03/25/2021
• Initial Report FDA Received Date: 03/12/2021
• Supplement Report FDA Received Date: 04/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 83 YR