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	05/21/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the radial vein.A 5.0 x40, 75cm gladiator elite balloon catheter was advanced for dilatation.However, during inflation, the balloon burst when the pressure reached to the working pressure.The procedure was completed with another of the same device.There were no patient complications reported and the patient status was stable.
Additional Manufacturer Narrative
Device evaluated by mfr.: gladiator device 5x40x75cm was received for analysis.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 longitudinal tear beginning approximately 2mm proximal of the proximal markerband and extending approximately 45mm distally across the balloon material.An examination of the balloon material and markerbands identified no issues which could potentially have contributed to this complaint.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 damage to the tip.This type of damage most probably occurred due to excessive force being applied to the device when attempting to advance/cross the lesion.No issues were identified during the product analysis.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the radial vein.A 5.0 x40, 75cm gladiator elite balloon catheter was advanced for dilatation.However, during inflation, the balloon burst when the pressure reached to the working pressure.The procedure was completed with another of the same device.There were no patient complications reported and the patient 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: 10212843
• Report Number: 2134265-2020-08727
• Device Sequence Number: 13983524
• Product Code: LIT
• UDI-Device Identifier: 08714729809678
• UDI-Public: 08714729809678
• 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): 08/05/2020

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: 09/03/2022
• Device Model Number: 24686
• Device Catalogue Number: 24686
• Device Lot Number: 0024375197
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2020
• Initial Date Received by Manufacturer: 06/24/2020
• Supplement Date Received by Manufacturer: 07/30/2020
• Initial Report FDA Received Date: 06/30/2020
• Supplement Report FDA Received Date: 08/05/2020
• 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: 64