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	02/02/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was in the left upper extremity.A 4.0 x40, 75cm gladiator elite balloon was selected to dilate the artificial blood vessel.During the procedure, the balloon was introduced into the venous stenosis of the artificial blood vessel along the guidewire and dilated under 10-22 atmospheres twice.After 30-60 seconds, the blood vessel was dilated under 22-24 atmospheres for the second time.It was found that the pressure decreased, and it was considered that the balloon was broken.After the balloon was pulled out, it was found that the balloon was ruptured laterally.Therefore, the balloon was replaced with one of another brand for balloon dilation.The patient recovered well after procedure.There were no complications reported and the patient was stable.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was in the left upper extremity.A 4.0 x40, 75cm gladiator elite balloon was selected to dilate the artificial blood vessel.During the procedure, the balloon was introduced into the venous stenosis of the artificial blood vessel along the guidewire and dilated under 10-22 atmospheres twice.After 30-60 seconds, the blood vessel was dilated under 22-24 atmospheres for the second time.It was found that the pressure decreased, and it was considered that the balloon was broken.After the balloon was pulled out, it was found that the balloon was ruptured laterally.Therefore, the balloon was replaced with one of another brand for balloon dilation.The patient recovered well after procedure.There were no complications reported and the patient was stable.
Additional Manufacturer Narrative
Device evaluated by mfr.: a gladiator device was received for analysis.A complete balloon circumferential tear was identified located approximately 25mm proximal of the distal tip.The distal section of the balloon was pulled in a distal direction over the distal tip.The rated burst pressure for this device as per gladiator specification is 24 atmospheres.A visual and tactile examination found no issues with the shaft of the device.

• 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: 18651039
• Report Number: 2124215-2024-06289
• Device Sequence Number: 7255738
• Product Code: LIT
• UDI-Device Identifier: 08714729809616
• UDI-Public: 08714729809616
• 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,Followup
• Report Date (Section B): 03/24/2024

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: 07/20/2025
• Device Model Number: 24686
• Device Catalogue Number: 24686
• Device Lot Number: 0029797318
• 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: 02/04/2024
• Supplement Date Received by Manufacturer: 03/08/2024
• Initial Report FDA Received Date: 02/06/2024
• Supplement Report FDA Received Date: 03/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/21/2022
• 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: 48 YR
• Patient Sex: Unknown
• Patient Weight: 70 KG