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

Model Number	24686
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/04/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The patient underwent balloon dilatation of vascular stenosis at stoma site.A 5.0 x40, 75cm gladiator balloon catheter was advanced for dilatation.However, during the procedure, the balloon was burst under pressure.The procedure was completed with another of same device.There were no patient complications reported and the patient status was stable.
Event or Problem Description
It was reported that balloon rupture occurred.The patient underwent balloon dilatation of vascular stenosis at stoma site.A 5.0 x40, 75cm gladiator balloon catheter was advanced for dilatation.However, during the procedure, the balloon was burst under pressure.The procedure was completed with another of same device.There were no patient complications reported and the patient status was stable.It was further reported that the balloon was inflated once at below working pressure.The device was simply pulled out from the patient's body.
Additional Manufacturer Narrative
Device evaluated by mfr.: gladiator elite 5.0 x40, 75cm was received for analysis: an examination of the returned device identified that the balloon had been inflated and was not refolded.A balloon longitudinal tear was identified beginning approximately 3mm distal of the distal markerband and extending approximately 22mm proximally across the balloon material.An examination of the balloon material and markerbands identified no issues which could potentially have contributed to this complaint.A visual examination of the markerbands identified no issues which may potentially have contributed to the complaint incident.A visual and tactile examination found no kinks or damage to the shaft of the device.A visual examination identified no issues or damage to the tip of the device.
Event or Problem Description
It was reported that balloon rupture occurred.The patient underwent balloon dilatation of vascular stenosis at stoma site.A 5.0 x40, 75cm gladiator balloon catheter was advanced for dilatation.However, during the procedure, the balloon was burst under pressure.The procedure was completed with another of same device.There were no patient complications reported and the patient status was stable.It was further reported that the balloon was inflated once at below working pressure.The device was simply pulled out from the patient's body.

• 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: 15037056
• Report Number: 2124215-2022-26031
• Device Sequence Number: 5138925
• Product Code: LIT
• UDI-Device Identifier: 08714729809678
• UDI-Public: 08714729809678
• 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: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/23/2022

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: 08/18/2024
• Device Model Number: 24686
• Device Catalogue Number: 24686
• Device Lot Number: 0027865453
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/09/2022
• Supplement Date Received by Manufacturer: 07/14/2022; 08/19/2022
• Initial Report FDA Received Date: 07/18/2022
• Supplement Report FDA Received Date: 07/20/2022; 08/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/19/2021
• 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 Age: 52 YR
• Patient Sex: Female
• Patient Weight: 53 KG