MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RANGER PACLITAXEL-COATED PTA BALLOON CATHETER; DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETER

Model Number 1973-03

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/30/2022

Event Type  malfunction  

Event Description

It was reported that the drug on the balloon was missing.A ranger paclitaxel-coated pta 4.0mm x 40mm, 135cm balloon catheter was selected for endovascular therapy.During removal from the package, it was noticed that the drug on this device looked like it was missing.The device was not used, and the procedure was completed successfully.No reported patient complications.

Manufacturer Narrative

Device eval by manufacturer: the returned product consisted of a ranger drug coated balloon catheter with batch 01514h22.It was noted that the balloon protector was not present on the shipped device.Upon visual inspection, the drug coating was present throughout the distance between the gold marker bands.The coating appeared uniform and had a distinct white to whitish optical appearance.Despite being shipped without a balloon protector, analysis confirmed that the drug coating was present on the balloon and undamaged.

Event Description

It was reported that the drug on the balloon was missing.A ranger paclitaxel-coated pta 4.0mm x 40mm, 135cm balloon catheter was selected for endovascular therapy.During removal from the package, it was noticed that the drug on this device looked like it was missing.The device was not used, and the procedure was completed successfully.No reported patient complications.

• Brand Name: RANGER PACLITAXEL-COATED PTA BALLOON CATHETER
• Type of Device: 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: 15834216
• MDR Text Key: 307584510
• Report Number: 2124215-2022-47427
• Device Sequence Number: 1
• Product Code: ONU
• UDI-Device Identifier: 08714729975762
• UDI-Public: 08714729975762
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P190019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/11/2023

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
• Device Operator: Health Professional
• Device Expiration Date: 02/16/2024
• Device Model Number: 1973-03
• Device Catalogue Number: 1973-03
• Device Lot Number: 01514H22
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/08/2022
• Initial Date FDA Received: 11/21/2022
• Supplement Dates Manufacturer Received: 01/04/2023
• Supplement Dates FDA Received: 01/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/16/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1