MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RANGER; CATHETER, PERCUTANEOUS

Model Number 1177-01

Device Problem Failure to Deflate (4060)

Patient Problem Perforation of Vessels (2135)

Event Date 07/24/2023

Event Type  Injury  

Event Description

It was reported that the balloon would not deflate, causing vessel trauma upon removal.This 7.0 mm x 40 mm, 135 cm ranger balloon was selected for use in a percutaneous transluminal angioplasty procedure of an arm dialysis fistula.During the procedure, the balloon was inflated for three minutes in the lesion.Balloon deflation was attempted several times without success.Therefore, the balloon was removed while inflated with the guidewire and sheath, causing vessel trauma.It was further noted that this created a rather large arteriotomy at the access site.Manual pressure was applied to the site for a prolonged amount of time.The patient fully recovered.

• Brand Name: RANGER
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC; 300 boston scientific way; marlborough MA 01752
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17550862
• MDR Text Key: 321193585
• Report Number: 2124215-2023-41406
• Device Sequence Number: 1
• Product Code: ONU
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1177-01
• Device Catalogue Number: 1177-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/24/2023
• Initial Date FDA Received: 08/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention