MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RANGER SL; CATHETER, PERCUTANEOUS

Model Number 1584-01

Device Problem Material Rupture (1546)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/09/2024

Event Type  malfunction  

Event Description

It was reported that balloon rupture occurred.The 80% stenosed target lesion was located in the mild tortuous and mild calcified popliteal artery.A 4.00mm x 150mm, 150cm ranger sl balloon catheter was advanced for dilation.During the procedure, the balloon ruptured upon first inflation at rated burst pressure.The device was removed without any problem, and the procedure was completed with another of the same device no complications were reported, and the patient was stable.

Manufacturer Narrative

Device evaluated by mfr: the ranger was returned for analysis.The returned device was attached to a boston scientific encore inflation unit and the balloon was inflated to its rated burst pressure with no leaks or issues noted.The markerbands and blades and tip section of the device were visually examined, and no issues were noted with the markerbands or tip of the device.A visual and tactile examination of the hypotube shaft found no issues with the shaft.

Event Description

It was reported that balloon rupture occurred.The 80% stenosed target lesion was located in the mild tortuous and mild calcified popliteal artery.A 4.00mm x 150mm, 150cm ranger sl balloon catheter was advanced for dilation.During the procedure, the balloon ruptured upon first inflation at rated burst pressure.The device was removed without any problem, and the procedure was completed with another of the same device no complications were reported, and the patient was stable.

• Brand Name: RANGER SL
• Type of Device: CATHETER, PERCUTANEOUS
• 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: 19201760
• MDR Text Key: 341267970
• Report Number: 2124215-2024-25535
• Device Sequence Number: 1
• Product Code: ONU
• Combination Product (y/n): Y
• Reporter Country Code: TW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/21/2024

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
• Device Operator: Health Professional
• Device Model Number: 1584-01
• Device Catalogue Number: 1584-01
• Device Lot Number: 07401H22
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/11/2024
• Initial Date FDA Received: 04/29/2024
• Supplement Dates Manufacturer Received: 05/03/2024
• Supplement Dates FDA Received: 05/21/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/18/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1