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	03/17/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in central vein.A 7.0 x40, 75cm gladiator elite balloon catheter was advanced for dilatation.However, during first inflation, when pressure was less than 10 atmospheres, the contrast agent leaked and the balloon ruptured.A hole on the side of the balloon was noted.The procedure was completed with another of the same device.There were no patient complications reported and the patient was stable.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in central vein.A 7.0 x40, 75cm gladiator elite balloon catheter was advanced for dilatation.However, during first inflation, when pressure was less than 10 atmospheres, the contrast agent leaked and the balloon ruptured.A hole on the side of the balloon was noted.The procedure was completed with another of the same device.There were no patient complications reported and the patient was stable.
Additional Manufacturer Narrative
Device evaluated by mfr: a visual examination identified that the balloon was not folded which indicates that the device was subjected to positive pressure.A microscopic examination identified a balloon pinhole located approximately 10mm distal of the proximal markerband.An examination of the balloon material and markerbands identified no issues which could potentially have contributed to this complaint.The rated burst pressure for this device is 20 atmospheres.A visual and microscopic 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 and tactile examination identified no issues or damage to the tip of the device.No other issues were identified during the product analysis.

• Brand Name: GLADIATOR ELITE
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11586611
• Report Number: 2134265-2021-04054
• Device Sequence Number: 11836444
• Product Code: LIT
• UDI-Device Identifier: 08714729809791
• UDI-Public: 08714729809791
• 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: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/06/2021

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: 06/15/2023
• Device Model Number: 24686
• Device Catalogue Number: 24686
• Device Lot Number: 0025599601
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2021
• Initial Date Received by Manufacturer: 03/23/2021
• Supplement Date Received by Manufacturer: 04/22/2021
• Initial Report FDA Received Date: 03/29/2021
• Supplement Report FDA Received Date: 05/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Patient Weight: 51