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 Codes	Difficult to Remove (1528); Failure to Deflate (4060)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/28/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that balloon failed to deflate, requiring additional device for removal.The target lesion was located in the severely calcified vessel.A 6.0 x 60mm, 135cm ranger drug-coated balloon was selected for post intravascular lithotripsy (ivl) therapy.However, after the balloon was inflated for 3 minutes, it was noted that the balloon would not deflate.The balloon would not deflate enough to be removed from a 6f sheath even after multiple attempts.The physician ended up taking a microneedle and puncturing the artery to rupture the balloon.The balloon was then removed intact, and the procedure was completed using this device.No patient complications were reported.It was further reported that this event was reported via medwatch: mw5156335.Furthermore, the target lesion was located in the right superficial femoral artery.
Event or Problem Description
It was reported that balloon failed to deflate, requiring additional device for removal.The target lesion was located in the severely calcified vessel.A 6.0 x 60mm, 135cm ranger drug-coated balloon was selected for post intravascular lithotripsy (ivl) therapy.However, after the balloon was inflated for 3 minutes, it was noted that the balloon would not deflate.The balloon would not deflate enough to be removed from a 6f sheath even after multiple attempts.The physician ended up taking a microneedle and puncturing the artery to rupture the balloon.The balloon was then removed intact, and the procedure was completed using this device.No patient complications were reported.

• Brand Name: RANGER PACLITAXEL-COATED PTA BALLOON CATHETER
• Common Device Name: 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: 19578807
• Report Number: 2124215-2024-36027
• Device Sequence Number: 18266042
• Product Code: ONU
• UDI-Device Identifier: 08714729976103
• UDI-Public: 08714729976103
• Combination Product (Y/N): Y
• Initial Reporter State: OH
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/08/2024

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: 12/10/2025
• Device Model Number: 1973-03
• Device Catalogue Number: 1973-03
• Device Lot Number: 12608H23
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2024
• Supplement Date Received by Manufacturer: 07/16/2024
• Initial Report FDA Received Date: 06/20/2024
• Supplement Report FDA Received Date: 08/08/2024
• Date Device Manufactured: 12/11/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR
• Patient Sex: Female
• Patient Weight: 80 KG
• Patient Race: Black Or African American