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	Material Rupture (1546); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/06/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter state: (b)(6).
Event or Problem Description
It was reported that the balloon was ruptured.During the endovascular therapy for severe lower limb ischemia in the superficial femoral artery (sfa), the ranger paclitaxel-coated pta balloon catheter was selected for use.The target lesion in the sfa was 99% stenosed with severe calcification and tortuosity.The ranger was advanced to the target lesion and inflated to 10 atm of pressure.The balloon ruptured vertically after 10 seconds of inflation.The balloon and delivery system were removed without issue.The ranger was replaced with another ranger and the procedure was completed.There were no reported consequences to the patient.
Event or Problem Description
It was reported that the balloon was ruptured.During the endovascular therapy for severe lower limb ischemia in the superficial femoral artery (sfa), the ranger paclitaxel-coated pta balloon catheter was selected for use.The target lesion in the sfa was 99% stenosed with severe calcification and tortuosity.The ranger was advanced to the target lesion and inflated to 10 atm of pressure.The balloon ruptured vertically after 10 seconds of inflation.The balloon and delivery system were removed without issue.The ranger was replaced with another ranger and the procedure was completed.There were no reported consequences to the patient.
Additional Manufacturer Narrative
E1: (b)(6).Device eval by manufacturer: 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.
Additional Manufacturer Narrative
E1: initial reporter state: (b)(6).Updated fields: b5 - describe event or problem: event description updated to reflect the absence of complaint allegation.D9 - device avail for evaluation, returned to manufacturer date: although the device was returned, the device evaluation will be documented under the original complaint record.A supplementary mdr will be submitted for device evaluation under report number 2124215-2022-33714.G1 - mfr contact first name, mfr contact last name, mfr contact phone number, mfr contact email.H3 - rfb device eval by mfr: although the device was returned, the device evaluation will be documented under the original complaint record.A supplementary mdr will be submitted for device evaluation under report number 2124215-2022-33714.H6 - device codes: updated to reflect the absence of a device deficiency.
Event or Problem Description
It was initially reported that the balloon was ruptured.However, additional information was received that indicated there was no longer any allegation of device deficiency.The event did not occur as originally reported.The initial report of balloon rupture had been misreported by the sales representative.The event was adequately reported under report number 2124215-2022-33714 and any subsequent supplementary reports.

• 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: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 15673640
• Report Number: 2124215-2022-41789
• Device Sequence Number: 6348585
• 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,Followup
• Report Date (Section B): 04/07/2023

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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/06/2022
• Supplement Date Received by Manufacturer: 10/31/2022; 03/13/2023
• Initial Report FDA Received Date: 10/26/2022
• Supplement Report FDA Received Date: 11/17/2022; 04/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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