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	04/05/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the balloon ruptured.This ranger global dcb otw 7.0 x 100mm, 135cm was selected for use in an endovascular therapy procedure.The lesion was located in the superficial femoral artery (sfa) and was 99% stenosed, mildly tortuous, and moderately calcified.It was noted the balloon ruptured during the first inflation at 14 atmospheres for 30 seconds.The device was able to be removed, the procedure was completed with a different ranger balloon, and there was no patient injury.The device is expected to be returned.
Additional Manufacturer Narrative
Device eval by manufacturer: upon receipt at our post market quality assurance laboratory, this ranger global dcb otw 7.0 x 100mm, 135cm was visually and microscopically examined.Visual examination of the outer shaft, inner shaft, balloon, and tip revealed a longitudinal tear to the balloon 70 mm from the tip and was approximately 33 mm long.Microscopic examination revealed no additional damages, and 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 ruptured.This ranger global dcb otw 7.0 x 100mm, 135cm was selected for use in an endovascular therapy procedure.The lesion was located in the superficial femoral artery (sfa) and was 99% stenosed, mildly tortuous, and moderately calcified.It was noted the balloon ruptured during the first inflation at 14 atmospheres for 30 seconds.The device was able to be removed, the procedure was completed with a different ranger balloon, and there was no patient injury.The device is expected to be returned.

• 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: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16820268
• Report Number: 2124215-2023-16174
• Device Sequence Number: 17916319
• Product Code: ONU
• UDI-Device Identifier: 08714729976301
• UDI-Public: 08714729976301
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/02/2023

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: 05/30/2024
• Device Model Number: 1973-03
• Device Catalogue Number: 1973-03
• Device Lot Number: 04611H22
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/05/2023
• Supplement Date Received by Manufacturer: 04/27/2023
• Initial Report FDA Received Date: 04/26/2023
• Supplement Report FDA Received Date: 05/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/31/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown