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	Hematoma (1884)
Date of Event	01/29/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that balloon rupture and vessel hematoma occurred.The target lesion was located in a tortuous arteriovenous fistula in an upper limb.A 7.0 x 40, 40cm gladiator elite balloon catheter was advanced for dilatation.However, during first inflation at 24 atmospheres, the balloon rupture.The vessel was damaged and immediately formed hematoma.The physician used another of the same balloon to treat the hematoma and completed the procedure.No patient complications were reported and the patient's status was stable.
Additional Manufacturer Narrative
Device evaluated by mfr.: the device was returned for analysis.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.Blood was identified within the balloon which is evidence of a device leak.A microscopic examination identified a balloon longitudinal tear beginning at the proximal balloon bond and extending approximately 56mm distally across the balloon material.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 found no issues with the markerbands or tip of the device that could have contributed to the complaint incident.A visual and tactile examination identified no kinks or damage to the shaft of the device.No other issues were noted with the device during analysis.
Event or Problem Description
It was reported that balloon rupture and vessel hematoma occurred.The target lesion was located in a tortuous arteriovenous fistula in an upper limb.A 7.0 x 40, 40cm gladiator elite balloon catheter was advanced for dilatation.However, during first inflation at 24 atmospheres, the balloon rupture.The vessel was damaged and immediately formed hematoma.The physician used another of the same balloon to treat the hematoma and completed the procedure.No patient complications were reported and the patient's status was stable.

• 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: 8368086
• Report Number: 2134265-2019-01623
• Device Sequence Number: 1599670
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/14/2021
• Device Model Number: 24686
• Device Catalogue Number: 24686
• Device Lot Number: 22118537
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2019
• Initial Date Received by Manufacturer: 02/13/2019
• Supplement Date Received by Manufacturer: 03/15/2019
• Initial Report FDA Received Date: 02/25/2019
• Supplement Report FDA Received Date: 04/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 45 YR
• Patient Weight: 58