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

Model Number 1584-01

Device Problems Break (1069); Entrapment of Device (1212); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 02/10/2023

Event Type  malfunction  

Event Description

It was reported that the device and guidewire became stuck.A ranger 3.0mm x 150mm, 150cm was selected for use in a distal superficial femoral artery (sfa) atherectomy procedure for a mild stenosis.A non-bsc guidewire was placed across the stenosis and the ranger balloon was advanced, however, the catheter got stuck on the wire and required them to be withdrawn together.Observations revealed the balloon shaft squished and shaft separated on wire.The procedure was completed successfully using a new ranger without sequelae.

Event Description

It was reported that the device and guidewire became stuck.A ranger 3.0mm x 150mm, 150cm was selected for use in a distal superficial femoral artery (sfa) atherectomy procedure for a mild stenosis.A non-bsc guidewire was placed across the stenosis and the ranger balloon was advanced, however, the catheter got stuck on the wire and required them to be withdrawn together.Observations revealed the balloon shaft squashed and shaft separated on wire.The procedure was completed successfully using a new ranger without sequelae.

Manufacturer Narrative

Device eval by manufacturer: returned product consisted of a ranger sl drug-coated balloon catheter with a 0.018" glidewire advantage.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed that the inflation lumen had damage all along it and was separated 115.2 cm from the hub.The entire guidewire lumen of the device had buckling and was also separated from the hub and stuck onto the guidewire.Microscopic and further inspection of the remainder of the device presented no other damage or irregularities.Product analysis identified damages consistent with stuck on guidewire that was alleged from the field.

• 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: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16479591
• MDR Text Key: 310628458
• Report Number: 2124215-2023-09677
• Device Sequence Number: 1
• Product Code: ONU
• Combination Product (y/n): Y
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/10/2023

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
• Device Operator: Health Professional
• Device Expiration Date: 02/17/2023
• Device Model Number: 1584-01
• Device Catalogue Number: 1584-01
• Device Lot Number: 01258H21
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/10/2023
• Initial Date FDA Received: 03/03/2023
• Supplement Dates Manufacturer Received: 04/13/2023
• Supplement Dates FDA Received: 05/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/17/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: TERUMO GLIDEWIRE ADVANTAGE; TERUMO GLIDEWIRE ADVANTAGE