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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RANGER SL; CATHETER, PERCUTANEOUS
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BOSTON SCIENTIFIC CORPORATION RANGER SL; CATHETER, PERCUTANEOUS Back to Search Results
Model Number 1584-01
Device Problems Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Foreign Body In Patient (2687); Vascular Dissection (3160)
Event Date 06/08/2023
Event Type  Injury  
Event Description
It was reported that the tip of the device remained in the patient, requiring an additional device.There was also a dissection noted.This 4.00mm x 150mm, 150cm ranger sl balloon was selected for use in a percutaneous transluminal angioplasty procedure.The lesion was located in the left superficial femoral artery and exhibited a long- section occlusion.An antegrade approach was performed and a non-boston scientific guidewire was passed intraluminally, and pre-dilation was performed with a sterling balloon.Post-dilation was performed with this ranger balloon, and a dissection was noted, and that the tip of the device was torn off in the vessel.Attempts were made to aspirate the material without success.The sheath was exchanged; a new guide catheter was used, and the balloon material was able to be retrieved; however, not the 1.5mm tip.The tip was therefore stented to the vessel wall.
 
Manufacturer Narrative
Device eval by manufacturer: upon receipt at our post market quality assurance laboratory, this ranger sl balloon catheter was visually and microscopically examined.Visual examination revealed multiple kinks along the device.There was buckling to the inflation lumen at the distal end of the separation.The guidewire lumen was separated 140.4cm from the hub and appears to have been stretched prior to separating.There were two other sections of the guidewire lumen measuring 1cm and 34.3cm long.The inflation lumen was separated 147.3cm from the hub.Microscopic examination revealed no additional damages.The tip and a marker band were missing.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis found damage that would have contributed to the reported event.
 
Event Description
It was reported that the tip of the device remained in the patient, requiring an additional device.There was also a dissection noted.This 4.00mm x 150mm, 150cm ranger sl balloon was selected for use in a percutaneous transluminal angioplasty procedure.The lesion was located in the left superficial femoral artery and exhibited a long- section occlusion.An antegrade approach was performed and a non-boston scientific guidewire was passed intraluminally, and pre-dilation was performed with a sterling balloon.Post-dilation was performed with this ranger balloon, and a dissection was noted, and that the tip of the device was torn off in the vessel.Attempts were made to aspirate the material without success.The sheath was exchanged; a new guide catheter was used, and the balloon material was able to be retrieved; however, not the 1.5mm tip.The tip was therefore stented to the vessel wall.
 
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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 Key17248780
MDR Text Key318344607
Report Number2124215-2023-30923
Device Sequence Number1
Product Code ONU
Combination Product (y/n)Y
Reporter Country CodeGM
Number of Events Reported1
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 08/29/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/03/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number1584-01
Device Catalogue Number1584-01
Device Lot Number05944H22
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/09/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/26/2022
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient SexMale
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