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	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/08/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the balloon became entrapped on the guidewire.This ranger global dcb otw 6.0 x 100mm, 135cm was selected for use in a percutaneous angioplasty procedure.The lesion was in the superior femoral artery (sfa), was moderately tortuous and calcified, and was 75 percent stenosed.During the procedure, the balloon became stuck on the guidewire.The balloon and guidewire were removed as one unit.There was no patient injury.
Additional Manufacturer Narrative
Device eval by manufacturer: upon receipt at our post market quality assurance laboratory, this ranger global dcb otw 6.0 x 100mm, 135cm was returned with a 0.014 guidewire inside the device.The outer shaft, inner shaft, balloon, and tip were visually and microscopically examined.Visual examination revealed a kink to the shaft 90mm from the tip.Microscopic examination revealed no additional damages.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis was unable to confirm the clinical observation of guidewire entrapment; however, damage was found that may have contributed to the reported event.
Event or Problem Description
It was reported that the balloon became entrapped on the guidewire.This ranger global dcb otw 6.0 x 100mm, 135cm was selected for use in a percutaneous angioplasty procedure.The lesion was in the superior femoral artery (sfa), was moderately tortuous and calcified, and was 75 percent stenosed.During the procedure, the balloon became stuck on the guidewire.The balloon and guidewire were removed as one unit.There was no patient injury.

• Brand Name: RANGER PACLITAXEL-COATED PTA BALLOON CATHETER
• Common Device Name: DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• 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: 16597500
• Report Number: 2124215-2023-11609
• Device Sequence Number: 5310636
• Product Code: ONU
• UDI-Device Identifier: 08714729976141
• UDI-Public: 08714729976141
• 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): 04/24/2023

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: 08/02/2024
• Device Model Number: 1973-03
• Device Catalogue Number: 1973-03
• Device Lot Number: 04803H22
• 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: 03/08/2023
• Supplement Date Received by Manufacturer: 04/07/2023
• Initial Report FDA Received Date: 03/23/2023
• Supplement Report FDA Received Date: 04/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/03/2022
• 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