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 Deflation Problem (1149)

Patient Problems Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/11/2022

Event Type  Injury  

Event Description

It was reported that the balloon would not deflate, and some balloon material was left in the patient.A 7.0mm x 40mm, 135cm ranger paclitaxel-coated pta balloon catheter was selected for use in a peripheral intervention of the external iliac artery.During the procedure, the balloon was inflated at 8atm for three minutes, but the balloon would deflate following dilation.A needle was used to pop the balloon, but some of the balloon material was left inside the patient.The patient was taken to the or to open up the artery and retrieve the rest of the device.The procedure was not completed.No further patient complications were reported.

Event Description

It was reported that the balloon would not deflate, and some balloon material was left in the patient.A 7.0mm x 40mm, 135cm ranger paclitaxel-coated pta balloon catheter was selected for use in a peripheral intervention of the external iliac artery.During the procedure, the balloon was inflated at 8atm for three minutes, but the balloon would deflate following dilation.A needle was used to pop the balloon, but some of the balloon material was left inside the patient.The patient was taken to the or to open up the artery and retrieve the rest of the device.The procedure was not completed.No further patient complications were reported.It was further reported that the target lesion was moderately calcified, and all device fragments were successfully retrieved.The patient was fine.

• 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: 15175693
• MDR Text Key: 297341529
• Report Number: 2134265-2022-08370
• Device Sequence Number: 1
• Product Code: ONU
• UDI-Device Identifier: 08714729976240
• UDI-Public: 08714729976240
• 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: 08/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/07/2024
• Device Model Number: 1973-03
• Device Catalogue Number: 1973-03
• Device Lot Number: 02103H22
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/08/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention