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

Model Number 24686

Device Problem Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/08/2020

Event Type  Malfunction  

Manufacturer Narrative

Device evaluation by mfr. : gladiator device - 7x40x75cm was received for analysis. A visual examination identified that the balloon was not folded which indicates that the device was subjected to positive pressure. Blood was identified within the balloon which is evidence of a device leak. A microscopic examination identified a balloon longitudinal tear beginning at the proximal bond and extending approximately 20mm 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 no damage to the tip which may have potentially contributed to the complaint incident. No issues were identified during the product analysis.

Event Description

Reportable based on device analysis completed on 14aug2020. It was reported that crossing difficulty was encountered. The target lesion was located in the radial artery. A 7. 0 x40, 75cm gladiator balloon catheter was advanced but failed to cross the lesion. The procedure was completed with another of the same device. No patient complications were reported and the patient status was stable. However, returned device analysis revealed longitudinal balloon tear.

• Brand Name: GLADIATOR ELITE
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 10503252
• MDR Text Key: 206152142
• Report Number: 2134265-2020-12474
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (Y/N): N
• Reporter Country Code: CH
• PMA/PMN Number: K132810
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: COMPANY REPRESENTATIVE,DISTRI

Reporter Occupation

• Type of Report: Initial
• Report Date: 09/08/2020

1 Device Was Involved in the Event

0 PatientS WERE Involved in the Event:

• Date FDA Received: 09/08/2020
• Is This An Adverse Event Report?: No
• Is This A Product Problem Report?: Yes
• Device Operator: HEALTH PROFESSIONAL
• Device MODEL Number: 24686
• Device Catalogue Number: 24686
• Device LOT Number: 0023935718
• Was Device Available For Evaluation?: Device Returned To Manufacturer
• Date Returned to Manufacturer: 08/04/2020
• Is The Reporter A Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 08/14/2020
• Was Device Evaluated By Manufacturer?: Yes
• Date Device Manufactured: 06/11/2019
• Is The Device Single Use?: Yes
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial