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	08/12/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a balloon rupture occurred.The 99% stenosed target lesion was located in a severely tortuous and severely calcified superficial femoral artery.A 6.0 x 60mm, 80cm ranger paclitaxel-coated pta balloon catheter was selected to treat the severe limb ischemia in the endovascular treatment procedure.However, during the first inflation at 10 atmospheres for 2 seconds duration, the balloon ruptured vertically.After decompression, the device was removed from the body and the procedure was completed with another device of the same model.There were no patient complications reported.
Additional Manufacturer Narrative
Initial reporter province- (b)(6).
Additional Manufacturer Narrative
E1: initial reporter province- (b)(6).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 no damages.Microscopic examination revealed a pinhole in 15mm from the tip.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis confirmed there is a pinhole in the balloon.
Event or Problem Description
It was reported that a balloon rupture occurred.The 99% stenosed target lesion was located in a severely tortuous and severely calcified superficial femoral artery.A 6.0 x 60mm, 80cm ranger paclitaxel-coated pta balloon catheter was selected to treat the severe limb ischemia in the endovascular treatment procedure.However, during the first inflation at 10 atmospheres for 2 seconds duration, the balloon ruptured vertically.After decompression, the device was removed from the body and the procedure was completed with another device of the same model.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 ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15341922
• Report Number: 2124215-2022-33714
• Device Sequence Number: 19965669
• Product Code: ONU
• UDI-Device Identifier: 08714729976110
• UDI-Public: 08714729976110
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/06/2023

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: 01/04/2024
• Device Model Number: 1973-03
• Device Catalogue Number: 1973-03
• Device Lot Number: 00036H22
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/12/2022
• Supplement Date Received by Manufacturer: 03/17/2023
• Initial Report FDA Received Date: 09/01/2022
• Supplement Report FDA Received Date: 04/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/04/2022
• 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