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 Consequences Or Impact To Patient (2199)
Date of Event	12/24/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon pinhole was encountered.The target lesion was located in iliac vein artery.A 10.0 x80, 75cm gladiator elite balloon catheter was advanced for post-dilation.However, during inflation, the balloon was damaged and visible pinhole 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
E1: initial reporter facility name: (b)(6).Device evaluated by mfr.: a gladiator elite 10.0 x80, 75cm was returned for analysis.The returned device was loaded onto a mandrel and attached to an encore inflation unit.Positive pressure was applied, and pinhole leaks were identified 5 mm proximally from the proximal marker band & 25 mm distally from the proximal marker band.No other issues were noted.A visual and microscopic examination of the balloon material identified no other issues.The rated burst pressure for this device was 14 atmospheres.A visual and microscopic examination of the markerbands identified no issues.A visual and tactile examination identified no kinks or damage to the shaft.A visual and tactile examination identified no damage to the tip.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that balloon pinhole was encountered.The target lesion was located in iliac vein artery.A 10.0 x80, 75cm gladiator elite balloon catheter was advanced for post-dilation.However, during inflation, the balloon was damaged and visible pinhole was noted.The procedure was completed with another of the same device.There were no patient complications reported and the patient 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: 9986083
• Report Number: 2134265-2020-04756
• Device Sequence Number: 3896341
• Product Code: LIT
• UDI-Device Identifier: 08714729826415
• UDI-Public: 08714729826415
• 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): 06/08/2020

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: 05/12/2022
• Device Model Number: 24686
• Device Catalogue Number: 24686
• Device Lot Number: 0023784415
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2020
• Initial Date Received by Manufacturer: 03/31/2020
• Supplement Date Received by Manufacturer: 05/13/2020
• Initial Report FDA Received Date: 04/22/2020
• Supplement Report FDA Received Date: 06/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1