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	10/20/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter facility name: (b)(6) hospital.Initial reporter state: (b)(6).
Event or Problem Description
It was reported that the balloon ruptured.A ranger global dcb otw 6.0 x 60mm, 135cm was selected for use in the proximal superficial femoral artery (sfa).During the procedure, the balloon was advanced to the target lesion, which was 50% stenosed and had moderate calcification and tortuosity.The balloon was inflated once to 12 atm before it ruptured.The device was removed from the patient and the procedure was completed with another of the same device.No patient complications were reported, and the patient was in stable condition following the procedure.
Additional Manufacturer Narrative
E1: initial reporter facility name: (b)(6).E1 - initial reporter state: (b)(6).Device/media analysis: 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 no damages.Microscopic examination revealed a longitudinal tear 44mm from the tip that was approximately 27mm long.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.A ranger global dcb otw 6.0 x 60mm, 135cm was selected for use in the proximal superficial femoral artery (sfa).During the procedure, the balloon was advanced to the target lesion, which was 50% stenosed and had moderate calcification and tortuosity.The balloon was inflated once to 12 atm before it ruptured.The device was removed from the patient and the procedure was completed with another of the same device.No patient complications were reported, and the patient was in stable condition following the procedure.

• 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: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15756260
• Report Number: 2124215-2022-45470
• Device Sequence Number: 5127035
• Product Code: ONU
• UDI-Device Identifier: 08714729976103
• UDI-Public: 08714729976103
• 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): 12/20/2022

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: 03/07/2024
• Device Model Number: 1973-03
• Device Catalogue Number: 1973-03
• Device Lot Number: 02099H22
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/20/2022
• Supplement Date Received by Manufacturer: 11/30/2022
• Initial Report FDA Received Date: 11/08/2022
• Supplement Report FDA Received Date: 12/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/08/2022
• 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