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); Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/06/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that deflation slow and difficulty removal occurred.The 50% stenosed target lesion was located in the mildly tortuous and moderately calcified arm shunt.A 7.0 x60, 75cm gladiator balloon catheter was advanced for dilation and inflated at 5-8 atmospheres for 2 minutes but the balloon was not able to deflate completely.Balloons fluid mix was completely aspirated, however, the physician stated that the balloon retained air and the air bumbling the balloon prevented it from deflating and therefore had to be pulled out with great difficulty after all attempts to remove the residual air in the balloon was attempted.The balloon was finally removed with force and a gladiator elite 7x40x75 was used to complete the procedure.There were no patient complications reported.
Event or Problem Description
It was reported that deflation slow and difficulty removal occurred.The 50% stenosed target lesion was located in the mildly tortuous and moderately calcified arm shunt.A 7.0 x60, 75cm gladiator balloon catheter was advanced for dilation and inflated at 5-8 atmospheres for 2 minutes but the balloon was not able to deflate completely.Balloons fluid mix was completely aspirated, however, the physician stated that the balloon retained air and the air bumbling the balloon prevented it from deflating and therefore had to be pulled out with great difficulty after all attempts to remove the residual air in the balloon was attempted.The balloon was finally removed with force and a gladiator elite 7x40x75 was used to complete the procedure.There were no patient complications reported.
Additional Manufacturer Narrative
H6: device code for break was removed.Device evaluated by manufacturer: a gladiator device was received 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 of 20 atmospheres using inflation media glycerol/water and no leaks were noted.A vacuum was then applied, and the balloon deflated fully in 19 seconds.The deflation time was verified using digital timer.The deflation time from rated burst pressure must be less than or equal to 60 seconds.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 19, 17, 16 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 examination observed no damage to the tip of the device.A visual and tactile examination identified no issues with the shaft of the device.A visual examination found no issues or damage to the markerbands of the device.

• Brand Name: GLADIATOR ELITE
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; pmt 741 persiaran cassia selat; bandarcassia, pulau pinan 14110 ; MY 14110
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15624746
• Report Number: 2124215-2022-42025
• Device Sequence Number: 6461205
• Product Code: LIT
• UDI-Device Identifier: 08714729809814
• UDI-Public: 08714729809814
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/30/2022

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: 08/25/2024
• Device Model Number: 24686
• Device Catalogue Number: 24686
• Device Lot Number: 0027908287
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/06/2022
• Supplement Date Received by Manufacturer: 11/04/2022
• Initial Report FDA Received Date: 10/18/2022
• Supplement Report FDA Received Date: 11/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/26/2021
• 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