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	07/31/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the cephalic vein.A 10.0 x40, 75cm gladiator elite was advanced for dilatation.However, during the initial inflation at 13 atmospheres, the balloon ruptured.The procedure was completed with another of the same device.No patient complications nor injuries reported and the patient's status was stable.
Additional Manufacturer Narrative
Device evaluated by mfr.: gladiator elite 10.0 x40, 75cm was returned 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 complete circumferential tear located approximately 10mm distal of the proximal markerband.The distal section of balloon material measuring approximately 10mm had been pulled over the distal tip and was also found to be torn longitudinally along its entire length.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 no damage to the tip of the device.A visual and tactile examination found the shaft of the device to be severely kinked at more than one location along its entire length.This type of damage is consistent with excessive force being applied to the device.A visual examination found no issues or damage to the markerbands of the device.No other 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 cephalic vein.A 10.0 x40, 75cm gladiator elite was advanced for dilatation.However, during the initial inflation at 13 atmospheres, the balloon ruptured.The procedure was completed with another of the same device.No patient complications nor injuries 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: 10382846
• Report Number: 2134265-2020-10780
• Device Sequence Number: 2186177
• Product Code: LIT
• UDI-Device Identifier: 08714729809517
• UDI-Public: 08714729809517
• 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): 09/29/2020

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: 09/26/2022
• Device Model Number: 24686
• Device Catalogue Number: 24686
• Device Lot Number: 0024502417
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2020
• Initial Date Received by Manufacturer: 08/03/2020
• Supplement Date Received by Manufacturer: 09/22/2020
• Initial Report FDA Received Date: 08/07/2020
• Supplement Report FDA Received Date: 09/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 46 YR
• Patient Weight: 53