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	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/06/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that a balloon rupture occurred.The 100% stenosed target lesion was located in the mildly tortuous and severely calcified superficial femoral artery.A 6.0 x 100mm, 135cm ranger paclitaxel-coated pta balloon catheter was selected to treat the lower limb arterial stenosis.However, during the first inflation at 14 atmospheres for one minute duration time, the balloon ruptured in a pinhole shape.After decompression, the device was removed from the body and the procedure was completed with a different device.There were no patient complications reported.

• 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 ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 14844051
• Report Number: 2134265-2022-07303
• Device Sequence Number: 2367704
• Product Code: ONU
• UDI-Device Identifier: 08714729976141
• UDI-Public: 08714729976141
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/28/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/27/2023
• Device Model Number: 1973-03
• Device Catalogue Number: 1973-03
• Device Lot Number: 06089H21
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/06/2022
• Initial Report FDA Received Date: 06/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/27/2021
• 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
• Patient Sex: Unknown