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 Difficult to Remove (1528)

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

Event Date 12/06/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

It was reported there was difficulty removing the device.A ranger paclitaxel-coated balloon catheter was selected for use in a left superficial femoral artery endovascular therapy procedure as treatment for peripheral artery disease.The procedure was being performed to treat 75% stenosis.The target lesion contained mild calcification and moderate tortuous severity.The physician was able to inflate the balloon and perform the procedure successfully, however upon removal the device was difficult to remove.It was noted that a brachial approach was utilized to remove the device.The procedure was able to be completed successfully without sequela.

Event Description

It was reported there was difficulty removing the device.A ranger paclitaxel-coated balloon catheter was selected for use in a left superficial femoral artery endovascular therapy procedure as treatment for peripheral artery disease.The procedure was being performed to treat 75% stenosis.The target lesion contained mild calcification and moderate tortuous severity.The physician was able to inflate the balloon and perform the procedure successfully, however upon removal the device was difficult to remove.It was noted that a brachial approach was utilized to remove the device.The procedure was able to be completed successfully without sequela.It was further reported that the device was removed in a loose curve-like state from the patient.The device was intact when removed.There were no patient complications.

Manufacturer Narrative

Initial reporter facility name: (b)(6) hospital.

Event Description

It was reported there was difficulty removing the device.A ranger paclitaxel-coated balloon catheter was selected for use in a left superficial femoral artery endovascular therapy procedure as treatment for peripheral artery disease.The procedure was being performed to treat 75% stenosis.The target lesion contained mild calcification and moderate tortuous severity.The physician was able to inflate the balloon and perform the procedure successfully, however upon removal the device was difficult to remove.It was noted that a brachial approach was utilized to remove the device.The procedure was able to be completed successfully without sequela.It was further reported that the device was removed in a loose curve-like state from the patient.The device was intact when removed.There were no patient complications.

Manufacturer Narrative

Initial reporter facility name: (b)(6) hospital.Device evaluated by mfr: 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 that the inflation lumen is stretched at the strain relief and 2.8cm from the strain relief.Microscopic examination revealed that the inflation lumen is twisted at the stretched sections.Inspection of the remainder of the device presented no other damage or irregularities.

• 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): BOSTON SCIENTIFIC CORPORATION; 500 commander shea boulevard; quincy MA 02171
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13046335
• MDR Text Key: 282559185
• Report Number: 2134265-2021-15787
• Device Sequence Number: 1
• Product Code: ONU
• UDI-Device Identifier: 08714729976141
• UDI-Public: 08714729976141
• 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,Followup
• Report Date: 02/16/2022

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: 11/25/2022
• Device Model Number: 1973-03
• Device Catalogue Number: 1973-03
• Device Lot Number: 0027582593
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/06/2021
• Initial Date FDA Received: 12/20/2021
• Supplement Dates Manufacturer Received: 12/24/2021; 01/25/2022
• Supplement Dates FDA Received: 01/19/2022; 02/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/25/2020
• 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