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

Model Number 24686

Device Problem Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/21/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that balloon rupture occurred.The target lesion was located in the median cubital vein.A 5.0 x 40, 75cm gladiator elite balloon catheter was advanced for dilatation.However, when the pressure was increased to 16 atmospheres during the second inflation, the balloon ruptured.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.

Manufacturer Narrative

Initial reporter facility name: (b)(6).Device evaluated by mfr.: gladiator elite 5.0 x 40, 75 cm device 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 microscopic examination identified a balloon longitudinal tear starting at approximately 4 mm distal of the proximal markerband extending for a length of approximately 24 mm distally.A visual and microscopic examination observed no issues with the tip of the device which could potentially have contributed to the complaint incident.A visual and tactile examination found no kinks or damage along the shaft of the device.No other issues were identified during the product analysis.

Event Description

It was reported that balloon rupture occurred.The target lesion was located in the median cubital vein.A 5.0 x40, 75cm gladiator elite balloon catheter was advanced for dilatation.However, when the pressue was increased to 16 atmospheres during the second inflation, the balloon ruptured.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.

• Brand Name: GLADIATOR ELITE
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8952815
• MDR Text Key: 156299052
• Report Number: 2134265-2019-10497
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 08714729809678
• UDI-Public: 08714729809678
• Combination Product (y/n): N
• PMA/PMN Number: K132810
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 09/30/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 01/14/2022
• Device Model Number: 24686
• Device Catalogue Number: 24686
• Device Lot Number: 0023192296
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2019
• Initial Date Manufacturer Received: 08/23/2019
• Initial Date FDA Received: 08/30/2019
• Supplement Dates Manufacturer Received: 09/12/2019
• Supplement Dates FDA Received: 09/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 77 YR
• Patient Weight: 56