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

Model Number	1973-03
Medical Device Problem Codes	Leak/Splash (1354); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/20/2023
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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 a longitudinal tear to the balloon 8mm from the tip and was approximately 28mm long.Microscopic examination revealed no additional damages.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis confirmed there was a longitudinal tear in the balloon.
Event or Problem 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
• Common Device Name: 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: 17225425
• Report Number: 2124215-2023-33934
• Device Sequence Number: 7076152
• Product Code: ONU
• UDI-Device Identifier: 08714729976189
• UDI-Public: 08714729976189
• Combination Product (Y/N): Y
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: P190019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/24/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/08/2024
• Device Model Number: 1973-03
• Device Catalogue Number: 1973-03
• Device Lot Number: 06330H22
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/26/2023
• Supplement Date Received by Manufacturer: 07/21/2023
• Initial Report FDA Received Date: 06/29/2023
• Supplement Report FDA Received Date: 07/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/09/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown