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

Model Number 1973-03

Device Problems Deflation Problem (1149); Leak/Splash (1354)

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

Event Date 02/02/2023

Event Type  malfunction  

Manufacturer Narrative

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 hole in the guidewire lumen 51mm from the tip.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis found damage that would have contributed to the leak.

Event Description

It was reported that the balloon was leaking contrast media, and was deflating slowly.A ranger 5x6mm was selected for use in the left superficial femoral artery (sfa) to treat the patient's stenosis.The target lesion was reported to be 90% stenosed with mild tortuosity and calcification.The lesion was predilated using a wolverine 4mm.The ranger was advanced to the target lesion and attempted to be inflated at 6 atm, but the pressure decreased.The balloon was attempted to be deflated but was deflating slowly.The balloon was able to fully deflate and was removed from the patient.When inspected outside of the patient, it was reported that contrast media was leaking from the balloon.The ranger was replaced with another in order to complete the procedure.There were no adverse patient consequences reported.

• 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: 16468895
• MDR Text Key: 310525134
• Report Number: 2124215-2023-06924
• Device Sequence Number: 1
• Product Code: ONU
• UDI-Device Identifier: 08714729975953
• UDI-Public: 08714729975953
• Combination Product (y/n): Y
• Reporter Country Code: JA
• PMA/PMN Number: P190019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/26/2023
• Device Model Number: 1973-03
• Device Catalogue Number: 1973-03
• Device Lot Number: 06770H21
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/26/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: RANGER 5X6MM; WOLVERINE 4MM
• Patient Sex: Male