MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION GLADIATOR ELITE; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	24686
Medical Device Problem Codes	Difficult to Remove (1528); Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/01/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that balloon rupture and removal difficulties occurred.The patient presented with iliac vein compression.The target lesion was located in the inferior vena cava.A 5.0 x40, 75cm gladiator elite was advanced for dilatation.However, during inflation at 18 atmospheres, the balloon ruptured and could not be withdrawn.The physician then cut the delivery system and removed the balloon by surgical incision.The procedure was completed with another of the same device.There were no patient complications reported and the patient status was stable.
Event or Problem Description
It was reported that balloon rupture and removal difficulties occurred.The patient presented with iliac vein compression.The target lesion was located in the inferior vena cava.A 5.0 x40, 75cm gladiator elite was advanced for dilatation.However, during inflation at 18 atmospheres, the balloon ruptured and could not be withdrawn.The physician then cut the delivery system and removed the balloon by surgical incision.The procedure was completed with another of the same device.There were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 5 x 40, 75cm was received for analysis.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.A complete circumferential tear was identified located approximately 9mm proximal of the distal markerband.An examination of the markerbands identified no issues which could potentially have contributed to this complaint.A visual and tactile examination found the shaft of the device to have completely detached at approximately 35mm proximal to the proximal balloon sleeve.This type of damage was as the result of the physician cutting the balloon delivery system as reported in the complaint event description.A visual and microscopic examination identified no damage to the markerbands.Tip damage was noted.This type of damage is consistant with excessive forece being applied to the device when attempting to cross the lesion.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: 10606591
• Report Number: 2134265-2020-13247
• Device Sequence Number: 16879160
• 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): 11/10/2020

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: 08/19/2022
• Device Model Number: 24686
• Device Catalogue Number: 24686
• Device Lot Number: 0024297837
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2020
• Initial Date Received by Manufacturer: 09/18/2020
• Supplement Date Received by Manufacturer: 10/27/2020
• Initial Report FDA Received Date: 09/30/2020
• Supplement Report FDA Received Date: 11/10/2020
• 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: 55 YR
• Patient Weight: 65