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

Model Number	1973-03
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/11/2022
Type of Reportable Event	Serious Injury
Event or Problem 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 or Problem 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
• Common Device Name: 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
• Report Number: 2134265-2022-08370
• Device Sequence Number: 17709630
• Product Code: ONU
• UDI-Device Identifier: 08714729976240
• UDI-Public: 08714729976240
• Combination Product (Y/N): Y
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P190019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2022

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?: Yes
• Operator of Device: 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/11/2022
• Supplement Date Received by Manufacturer: 08/05/2022
• Initial Report FDA Received Date: 08/05/2022
• Supplement Report FDA Received Date: 08/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/08/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown