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 Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/30/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the balloon burst.A 5.0 x 40mm, 135cm ranger paclitaxel-coated pta balloon catheter was selected for use in an angioplasty procedure in the right profunda.The 60% target lesion was mildly calcified and located in non-tortuous anatomy.After atherectomy was performed, the ranger balloon was put in place.Upon inflation, the balloon burst at 4atm in less than 5 seconds.The balloon was taken out and inspected.No missing pieces from the balloon, and the shaft was still intact.The procedure was successfully completed with a 6.0 x 40mm, 135cm ranger paclitaxel-coated pta balloon catheter.No patient complications were reported.
Additional Manufacturer Narrative
Device eval by manufacturer: returned product consisted of a ranger drug coated balloon catheter.The outer shaft, inner shaft, balloon, and tip were visually and microscopically examined.Visual examination revealed a longitudinal tear to the balloon 8mm from the tip and was approximately 30mm long.Microscopic examination revealed no additional damages.
Event or Problem Description
It was reported that the balloon burst.A 5.0 x 40mm, 135cm ranger paclitaxel-coated pta balloon catheter was selected for use in an angioplasty procedure in the right profunda.The 60% target lesion was mildly calcified and located in non-tortuous anatomy.After atherectomy was performed, the ranger balloon was put in place.Upon inflation, the balloon burst at 4atm in less than 5 seconds.The balloon was taken out and inspected.No missing pieces from the balloon, and the shaft was still intact.The procedure was successfully completed with a 6.0 x 40mm, 135cm ranger paclitaxel-coated pta balloon catheter.No patient complications were reported.

• 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: 17176043
• Report Number: 2124215-2023-32056
• Device Sequence Number: 6461854
• Product Code: ONU
• UDI-Device Identifier: 08714729975922
• UDI-Public: 08714729975922
• Combination Product (Y/N): Y
• Initial Reporter State: WI
• 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): 07/20/2023

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: 04/11/2024
• Device Model Number: 1973-03
• Device Catalogue Number: 1973-03
• Device Lot Number: 03116H22
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/30/2023
• Supplement Date Received by Manufacturer: 06/29/2023
• Initial Report FDA Received Date: 06/21/2023
• Supplement Report FDA Received Date: 07/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/12/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown