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 Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/21/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the ro markers on the balloon could not be seen.A 6mm x 120mm, 150cm ranger paclitaxel-coated pta balloon catheter was selected for use in a superficial femoral artery intervention.During the procedure, the ro markers could not be seen on the balloon.Another balloon was used to complete the procedure.No patient complications were reported, and the patient is fine.
Additional Manufacturer Narrative
Corrections: b3 date of event was corrected from 23-dec-2021 to 21-dec-2021.Batch/lot # was corrected from 07445h20 to 06213h21.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 and microscopic examination revealed no damages.The device was placed into an x-ray and the marker bands were visible.Inspection of the remainder of the device presented no other damages or irregularities.Product analysis could not confirm the difficulty to view the marker band under fluoroscopy.
Event or Problem Description
It was reported that the ro markers on the balloon could not be seen.A 6mm x 120mm, 150cm ranger paclitaxel-coated pta balloon catheter was selected for use in a superficial femoral artery intervention.During the procedure, the ro markers could not be seen on the balloon.Another balloon was used to complete the procedure.No patient complications were reported, and the patient is fine.It was further reported via voluntary medwatch/maude report list # mw5106319 that the balloon was never inflated.

• 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 ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13310985
• Report Number: 2134265-2022-00441
• Device Sequence Number: 17400463
• Product Code: ONU
• UDI-Device Identifier: 08714729976165
• UDI-Public: 08714729976165
• Combination Product (Y/N): Y
• Initial Reporter State: IN
• 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): 02/25/2022

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: 09/30/2023
• Device Model Number: 1973-03
• Device Catalogue Number: 1973-03
• Device Lot Number: 06213H21
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/28/2021
• Supplement Date Received by Manufacturer: 01/28/2022
• Initial Report FDA Received Date: 01/20/2022
• Supplement Report FDA Received Date: 02/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/30/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown