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 Device-Device Incompatibility (2919)

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

Event Date 10/14/2022

Event Type  malfunction  

Event Description

It was reported that the balloon catheter got stuck with a stent.A ranger paclitaxel-coated pta 6.0mm x 100mm, 80cm balloon catheter was selected for endovascular therapy to treat the right superficial femoral artery.The procedure was being performed to treat 75% stenosis, and the target lesion contained mild calcification and moderate tortuosity.During the procedure, the balloon catheter became stuck with another manufacturer stent.The catheter was removed as intended, and no fragments were left inside the patient.The procedure was not able to be completed, as another of the same device was not available.

Manufacturer Narrative

Device eval by manufacturer: returned product consisted of a ranger pta drug-coated balloon catheter from batch 02401h22.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined and revealed no damages.Further inspection of the remainder of the device presented no other damage or irregularities.Product analysis was not able to confirm the reported event from the field in a laboratory setting.

Event Description

It was reported that the balloon catheter got stuck with a stent.A ranger paclitaxel-coated pta 6.0mm x 100mm, 80cm balloon catheter was selected for endovascular therapy to treat the right superficial femoral artery.The procedure was being performed to treat 75% stenosis, and the target lesion contained mild calcification and moderate tortuosity.During the procedure, the balloon catheter became stuck with another manufacturer stent.The catheter was removed as intended, and no fragments were left inside the patient.The procedure was not able to be completed, as another of the same device was not available.

• 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: 15735716
• MDR Text Key: 307025285
• Report Number: 2124215-2022-45381
• Device Sequence Number: 1
• Product Code: ONU
• UDI-Device Identifier: 08714729976158
• UDI-Public: 08714729976158
• 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,Followup
• Report Date: 11/22/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 03/14/2024
• Device Model Number: 1973-03
• Device Catalogue Number: 1973-03
• Device Lot Number: 02401H22
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/14/2022
• Initial Date FDA Received: 11/04/2022
• Supplement Dates Manufacturer Received: 11/09/2022
• Supplement Dates FDA Received: 11/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/15/2022
• 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