MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY GLADIATOR¿; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number H74939207050270

Device Problems Device Damaged Prior to Use (2284); Torn Material (3024)

Patient Problem No Patient Involvement (2645)

Event Date 04/30/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluated by mfr.: it is indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental mdr will be filed.(b)(4).

Event Description

It was reported that balloon tear occurred.During unpacking of a 5.0 x20 75cm gladiator¿ balloon catheter, it was noted that there was a slit on the balloon material.The procedure was completed with another of the same device.No patient complications were reported.

• Brand Name: GLADIATOR¿
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 7538374
• MDR Text Key: 109108905
• Report Number: 2134265-2018-04487
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113681
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/27/2021
• Device Model Number: H74939207050270
• Device Catalogue Number: 3920705027
• Device Lot Number: 0021921112
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/01/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/28/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1