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

Model Number 24686

Device Problem Inflation Problem (1310)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/29/2023

Event Type  malfunction  

Event Description

Reportable based on device analysis completed on 18oct2023.It was reported that balloon inflation failure occurred.The 70% stenosed target lesion was located in the moderately tortuous and moderately calcified left arm.A 6.0 x40, 75cm gladiator elite balloon catheter was advanced for dilatation.However, during procedure, the balloon could not be inflated and after the removal of the device from the patient, it was found that the balloon could no longer be used.The device was simply removed, and the procedure was completed with another of the same device.No patient complications were reported, and the patient was stable.However, returned device analysis revealed balloon longitudinal and circumferential tear.

Manufacturer Narrative

E1: initial reporter address 1: (b)(6).E1: initial reporter phone: (b)(6).Device evaluated by mfr: gladiator elite 6.0 x40, 75cm was received for analysis.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.A partial balloon circumferential tear was identified located approximately 13mm distal of the proximal markerband.The balloon was also torn longitudinally beginning at the circumferential tear and extending approximately 13mm proximally across the balloon material.No other issues were noted with the balloon.As per gladiator specification the rated burst pressure for this device is 24 atmospheres.Due to the tears in the balloon material inflation of the device is not possible.A visual examination observed no damage to the tip of the device.A visual and tactile examination found no kinks or damage to the shaft of the device.A visual examination found both markerbands to be undamaged and present on the shaft of the device.

• Brand Name: GLADIATOR ELITE
• Type of Device: 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: 17972007
• MDR Text Key: 326363455
• Report Number: 2124215-2023-58064
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 08714729809739
• UDI-Public: 08714729809739
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K132810
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 24686
• Device Catalogue Number: 24686
• Device Lot Number: 0030088728
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/06/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 78 YR
• Patient Sex: Male
• Patient Weight: 45 KG