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

Model Number H74939207080470

Device Problem Material Rupture (1546)

Patient Problem No Code Available (3191)

Event Date 11/18/2015

Event Type  Injury  

Manufacturer Narrative

Age at time of event: around 30s.Device evaluated by mfr: it is indicated that the device will not be returned for evaluation.A review of the batch history, historical trending, and similar complaint trending review for the product family will be conducted.If there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).

Event Description

It was reported that balloon rupture occurred.The target lesion was located in a fistula in the left upper arm vessel.An 8.0mmx40mm, 75cm gladiator¿ balloon catheter was selected for use and advanced for dilation.However, upon inflation below the rated burst pressure, the balloon ruptured in a circumferential pattern.The physician was not able to retrieve the balloon back out through the sheath and the physician had to do a cut down to the artery into the fistula to completely remove the balloon.The patient did loose some blood but the physician was able to "stitch" the artery.The procedure was not completed.No further patient complications were reported and the patient's status was fine.

• Brand Name: GLADIATOR¿
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY
• Manufacturer Contact: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 5285452
• MDR Text Key: 33239068
• Report Number: 2134265-2015-08522
• 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: 11/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/14/2017
• Device Model Number: H74939207080470
• Device Catalogue Number: 3920708047
• Device Lot Number: 18400204
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/19/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/15/2015
• 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
• Patient Outcome(s): Required Intervention