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	05/18/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 - initial reporter phone: (b)(6).
Event or Problem Description
It was reported that balloon rupture occurred.The stenosed target lesion was located in an arteriovenous fistula.A 7.0 x40, 40cm gladiator elite balloon catheter was advanced for dilatation.However, during the procedure, the balloon burst.The procedure was completed with another of same device.There were no patient complications reported and the patient was stable post-procedure.
Event or Problem Description
It was reported that balloon rupture occurred.The stenosed target lesion was located in an arteriovenous fistula.A 7.0 x40, 40cm gladiator elite balloon catheter was advanced for dilatation.However, during the procedure, the balloon burst.The procedure was completed with another of same device.There were no patient complications reported and the patient was stable post-procedure.It was further reported that the 80% stenosed target lesion was moderately tortuous and severely calcified.The balloon ruptured during the sixth inflation at 20 atmospheres for 40-50 seconds.Neither a balloon nor a segment of the balloon detached inside the patient after it ruptured.
Additional Manufacturer Narrative
E1 - initial reporter phone: +(b)(6) device evaluated by mfr.: gladiator elite 7.0 x40, 40cm, was received for analysis.A visual examination identified that the balloon was not folded which indicates that the device was subjected to positive pressure.The returned device was attached to an encore inflation unit.Positive pressure was applied when liquid was observed to be leaking from a balloon pinhole located approximately 5mm distal of the distal markerband.The rated burst pressure for this device is 20 atmospheres as per gladiator specification.A visual examination observed no issues or damage to the tip of the device.A visual and tactile examination found no kinks or damage the shaft of the device.A visual examination observed no issues with the markerbands of the device.Both markerbands were undamaged and present on the shaft of the device.
Additional Manufacturer Narrative
E1 - initial reporter phone: (b)(6); e1: initial reporter address 1: corrected from no.(b)(6).
Event or Problem Description
It was reported that balloon rupture occurred.The stenosed target lesion was located in an arteriovenous fistula.A 7.0 x40, 40cm gladiator elite balloon catheter was advanced for dilatation.However, during the procedure, the balloon burst.The procedure was completed with another of same device.There were no patient complications reported and the patient was stable post-procedure.It was further reported that the 80% stenosed target lesion was moderately tortuous and severely calcified.The balloon ruptured during the sixth inflation at 20 atmospheres for 40-50 seconds.Neither a balloon nor a segment of the balloon detached inside the patient after it ruptured.

• 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: 17021351
• Report Number: 2124215-2023-26479
• Device Sequence Number: 7554896
• Product Code: LIT
• UDI-Device Identifier: 08714729809784
• UDI-Public: 08714729809784
• 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): 07/05/2023

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: 05/22/2025
• Device Model Number: 24686
• Device Catalogue Number: 24686
• Device Lot Number: 0029449741
• 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: 05/18/2023
• Supplement Date Received by Manufacturer: 05/29/2023; 06/29/2023
• Initial Report FDA Received Date: 05/30/2023
• Supplement Report FDA Received Date: 06/14/2023; 07/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/23/2022
• 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 Age: 59 YR
• Patient Sex: Male
• Patient Weight: 62 KG