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

Model Number 1584-01

Device Problems Break (1069); Material Rupture (1546); Difficult to Advance (2920); Material Integrity Problem (2978)

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

Event Date 02/18/2022

Event Type  malfunction  

Event Description

It was reported that a balloon burst occurred.The 50% stenosed target lesion is located in the moderately calcified and mildly tortuous tibial artery.A 4.00mm x 100mm, 150cm ranger sl was selected for use.During insertion, the distal part of the shaft was twisted and could not be advanced correctly over the 0.035 inch 260cm zipwire.The balloon was pulled out of the patient intact prior to starting angioplasty.The physician was inflating the balloon outside the patient at 6atm; however the balloon burst and the distal part of the shaft detached.A ranger sl 4x120mm was used to complete the procedure.There were no patient complications.

Manufacturer Narrative

Device evaluated by mfr: the ranger was received for analysis.Visual inspection of the device noted the balloon protector was on the device.Buckling of the entire catheter was visible.Microscopic examination showed kinks 1.6mm, 3.0mm and 8.0 cm from the hub.The device was unable to be inflated but a hole was found in the balloon close to the proximal marker band.

Event Description

It was reported that a balloon burst occurred.The 50% stenosed target lesion is located in the moderately calcified and mildly tortuous tibial artery.A 4.00mm x 100mm, 150cm ranger sl was selected for use.During insertion, the distal part of the shaft was twisted and could not be advanced correctly over the 0.035 inch 260cm zipwire.The balloon was pulled out of the patient intact prior to starting angioplasty.The physician was inflating the balloon outside the patient at 6atm; however the balloon burst and the distal part of the shaft detached.A ranger sl 4x120mm was used to complete the procedure.There were no patient complications.

• Brand Name: RANGER SL
• Type of Device: CATHETER, PERCUTANEOUS
• 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: 13790347
• MDR Text Key: 287354556
• Report Number: 2134265-2022-02947
• Device Sequence Number: 1
• Product Code: ONU
• Combination Product (y/n): Y
• Reporter Country Code: MX
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/19/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 10/13/2022
• Device Model Number: 1584-01
• Device Catalogue Number: 1584-01
• Device Lot Number: 06869H20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/18/2022
• Initial Date FDA Received: 03/16/2022
• Supplement Dates Manufacturer Received: 04/26/2022
• Supplement Dates FDA Received: 05/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/13/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: INTRODUCER SHEATH: 6F SUPERSHEATH; INTRODUCER SHEATH: 6F SUPERSHEATH
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Weight: 70 KG
• Patient Race: White