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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RANGER; CATHETER, PERCUTANEOUS
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BOSTON SCIENTIFIC CORPORATION RANGER; CATHETER, PERCUTANEOUS Back to Search Results
Model Number 1177-01
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Failure to Deflate (4060)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/31/2023
Event Type  Injury  
Event Description
It was reported that the balloon would not deflate, requiring the use of a snare.This 8.0 mm x 40 mm, 135 cm ranger balloon was selected for use in a drug-eluting balloon percutaneous transluminal angioplasty procedure.During the procedure, the balloon was inflated for two minutes.During deflation of the balloon, the balloon only deflated at the end.Extensive deflation attempts were not successful.A 9fr and later a 14fr non-boston scientific device were inserted to deflate the balloon with a snare, which was successful after intensive attempts.The balloon was then recovered with the snare via the 14fr device.After removal, it was noted that the balloon was still semi-bouncing.There were no patient complications.
 
Manufacturer Narrative
Device eval by manufacturer: upon receipt at our post market quality assurance laboratory, this ranger drug coated balloon catheter was returned with a 0.018 in guidewire stuck inside.The outer shaft, inner shaft, balloon, and tip were visually and microscopically examined.Visual examination revealed that the inflation lumen was separated 16.4 cm from the tip.The guidewire lumen was separated 9.7 cm from the tip.There were multiple bucklings to the inflation lumen and guidewire lumen.Microscopic examination revealed no additional damages.The inflation lumen was stretched at the separation.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis found damage that would have contributed to the failure to deflate.
 
Event Description
It was reported that the balloon would not deflate, requiring the use of a snare.This 8.0 mm x 40 mm, 135 cm ranger balloon was selected for use in a drug-eluting balloon percutaneous transluminal angioplasty procedure.During the procedure, the balloon was inflated for two minutes.During deflation of the balloon, the balloon only deflated at the end.Extensive deflation attempts were not successful.A 9fr and later a 14fr non-boston scientific device were inserted to deflate the balloon with a snare, which was successful after intensive attempts.The balloon was then recovered with the snare via the 14fr device.After removal, it was noted that the balloon was still semi-bouncing.There were no patient complications.
 
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Brand Name
RANGER
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 Key17606943
MDR Text Key321777529
Report Number2124215-2023-41905
Device Sequence Number1
Product Code ONU
Combination Product (y/n)Y
Reporter Country CodeSZ
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 11/20/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number1177-01
Device Catalogue Number1177-01
Device Lot Number06458H22
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 08/03/2023
Initial Date FDA Received08/23/2023
Supplement Dates Manufacturer Received11/14/2023
Supplement Dates FDA Received11/20/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/11/2022
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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