MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RANGER PACLITAXEL-COATED PTA BALLOON CATHETER; DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETER

Model Number 1973-03

Device Problems Leak/Splash (1354); Material Rupture (1546)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/20/2023

Event Type  malfunction  

Event Description

It was reported that the balloon burst and was leaking.A 6.0 x 150mm, 150cm ranger paclitaxel-coated pta balloon catheter was selected for use in a percutaneous transluminal angioplasty procedure.The very calcified lesion was located in the superficial femoral artery.The balloon developed a leak and burst during the first inflation at 6 atm for 30 seconds, and never reached full size.The balloon was removed intact, and a second balloon of the same size was then advanced to the lesion and inflated.Shortly after inflation, the balloon began losing pressure and was removed.The procedure was completed with another ranger balloon.There were no patient complications.

Manufacturer Narrative

Device eval by manufacturer: upon receipt at our post market quality assurance laboratory, this ranger paclitaxel-coated pta balloon catheter was visually and microscopically examined.Visual examination revealed no damages.Microscopic examination revealed a pinhole 65mm from the tip.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis confirmed there was a pinhole in the balloon.

Event Description

It was reported that the balloon burst and was leaking.A 6.0 x 150mm, 150cm ranger paclitaxel-coated pta balloon catheter was selected for use in a percutaneous transluminal angioplasty procedure.The very calcified lesion was located in the superficial femoral artery.The balloon developed a leak and burst during the first inflation at 6 atm for 30 seconds, and never reached full size.The balloon was removed intact, and a second balloon of the same size was then advanced to the lesion and inflated.Shortly after inflation, the balloon began losing pressure and was removed.The procedure was completed with another ranger balloon.There were no patient complications.

• Brand Name: RANGER PACLITAXEL-COATED PTA BALLOON CATHETER
• Type of Device: DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): HEMOTEQ AG; adenauerstrasse 15; wuerselen 52146 ; GM 52146
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17225386
• MDR Text Key: 318095101
• Report Number: 2124215-2023-33933
• Device Sequence Number: 1
• Product Code: ONU
• UDI-Device Identifier: 08714729976189
• UDI-Public: 08714729976189
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P190019
• 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,Followup
• Report Date: 07/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1973-03
• Device Catalogue Number: 1973-03
• Device Lot Number: 03273H22
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/27/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1