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

Model Number	24686
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/13/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Weight: (b)(6).
Event or Problem Description
It was reported that shaft break occurred.The target lesion was located in the internal fistula of the forearm.A 5.0 x40, 40cm gladiator balloon catheter was advanced.However, during procedure the catheter broke.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.
Event or Problem Description
It was reported that shaft break occurred.The target lesion was located in the internal fistula of the forearm.A 5.0 x40, 40cm gladiator balloon catheter was advanced.However, during procedure the catheter broke.The procedure was completed with another of same device.No patient complications were reported and the patient's status was stable.
Additional Manufacturer Narrative
(a4) weight: 57.4 kg.Device evaluated by mfr: gladiator device - 5x40x40cm 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 visual and microscopic examination found the balloon material to have a partial circumferential tear located approximately 11mm distal of the proximal markerband.The balloon material was also torn longitudinally beginning at the circumferential tear and extending approximately 8mm proximally 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 observed damage to the tip of the device.This type of damage is consistent with excessive force being applied to the device when crossing a lesion.A visual and tactile examination found the shaft of the device to be kinked at more than one location.This type of damage is consistent with excessive force being applied to the device when crossing a lesion.A visual examination found no issues or damage to the markerbands 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: 10390830
• Report Number: 2134265-2020-10061
• Device Sequence Number: 19568699
• Product Code: LIT
• UDI-Device Identifier: 08714729809661
• UDI-Public: 08714729809661
• 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): 09/11/2020

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: 08/20/2022
• Device Model Number: 24686
• Device Catalogue Number: 24686
• Device Lot Number: 0024305050
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2020
• Initial Date Received by Manufacturer: 07/21/2020
• Supplement Date Received by Manufacturer: 08/19/2020
• Initial Report FDA Received Date: 08/11/2020
• Supplement Report FDA Received Date: 09/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 55 YR