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

Model Number	24686
Medical Device Problem Codes	Inflation Problem (1310); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/11/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on device analysis completed on (b)(6) 2023.It was reported that balloon inflation failure and loading difficulties on wire occurred.The 70% stenosed target lesion was located in the tortuous and non-calcified arch of cephalic vein.An 8.0 x40, 75cm gladiator elite balloon catheter was advanced for dilatation, but the balloon was damaged and could not inflate despite application of pressure and the guidewire could not enter.The procedure was completed with another of the same device.There were no complications reported and the patient status was stable.However, returned device analysis revealed balloon longitudinal tear.
Additional Manufacturer Narrative
E1 initial reporter phone: (b)(6) device evaluated by mfr: gladiator elite 8.0 x40, 75cm was received for analysis.The recommended guidewire size for this device is 0.035-inch.The guidewire used by the customer was not returned for analysis.The investigator successfully loaded the device on to a boston scientific 0.035-inch guidewire without issue.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.A balloon longitudinal tear was identified beginning approximately 5mm proximal of the proximal markerband and extending approximately 24mm distally across the balloon material.The rated burst pressure for this device is 20 atmospheres.Due to the tear in the balloon material inflation of the device is not possible.A visual examination of the markerbands identified no issues.A visual and tactile examination found no kinks or damage to the shaft of the device.A visual examination identified no damage to the tip.

• Brand Name: GLADIATOR ELITE
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; pmt 741 persiaran cassia selat; bandarcassia, pulau pinan 14110 ; MY 14110
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18069980
• Report Number: 2124215-2023-61468
• Device Sequence Number: 7616018
• Product Code: LIT
• UDI-Device Identifier: 08714729809876
• UDI-Public: 08714729809876
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/03/2023

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: 08/02/2025
• Device Model Number: 24686
• Device Catalogue Number: 24686
• Device Lot Number: 0029881052
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/17/2023
• Initial Report FDA Received Date: 11/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/03/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown