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 Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Inflammation (1932); Pain (1994)

Event Date 05/23/2023

Event Type  Injury  

Event Description

It was reported patient experienced myositis reported to be caused by paclitaxel treatment.A ranger paclitaxel-coated pta balloon catheter was selected lower limb percutaneous transluminal angiography procedure of the superficial femoral artery for peripheral arterial disease.The target lesion was reported as 100% stenosed with mild tortuosity and moderate severity.The patient was returning a few weeks later for an additional treatment of the ipsilateral iliac case that was not treated previously; however, the patient reported very severe pain in the leg (especially below the popliteal fossa) and the muscle deviation enzyme had increased up to 2 since the last procedure.It was considered that it might be a compartment syndrome, but after a consultation with a plastic surgeon, it was different.They physician reported that the symptoms of myositis was considered to be caused by paclitaxel.The patient was administered antibiotics and 5l replacement fluid as treatment.

• Brand Name: RANGER PACLITAXEL-COATED PTA BALLOON CATHETER
• Type of Device: DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): HEMOTEQ AG; adenauerstrasse 15; wuerselen 52146 ; GM 52146
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17293395
• MDR Text Key: 318739286
• Report Number: 2124215-2023-36049
• Device Sequence Number: 1
• Product Code: ONU
• UDI-Device Identifier: 08714729976219
• UDI-Public: 08714729976219
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/11/2024
• Device Model Number: 1973-03
• Device Catalogue Number: 1973-03
• Device Lot Number: 03433H22
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/13/2023
• Initial Date FDA Received: 07/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/12/2022
• 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
• Patient Outcome(s): Required Intervention