• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RANGER PACLITAXEL-COATED PTA BALLOON CATHETER; DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETER

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BOSTON SCIENTIFIC CORPORATION RANGER PACLITAXEL-COATED PTA BALLOON CATHETER; DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETER Back to Search Results
Model Number 1973-03
Device Problem Defective Device (2588)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/03/2023
Event Type  malfunction  
Event Description
It was reported that the balloon length was shorter than expected.This ranger global dcb otw 6.0 x 60mm, 135cm was selected for use in a percutaneous angioplasty procedure.The lesion was in the superior femoral artery (sfa), was mildly calcified, had moderate tortuosity, and was 95 percent stenosed.During fluoroscopy during the procedure, it was suspected that the balloon length was 5.5cm instead of the expected 6cm.After the procedure the balloon length was measured outside the body and was 5.5cm.There was no patient injury.The device is expected to be returned.
 
Manufacturer Narrative
Device eval by manufacturer: upon receipt at our post market quality assurance laboratory, this ranger global dcb otw 6.0 x 60mm, 135cm was visually and microscopically examined.The outer shaft, inner shaft, balloon, and tip revealed no damages.Dimensional testing was performed by measuring the balloon from the proximal cone to the distal cone.The device measured within specifications.Inspection of the remainder of the device presented no damage or irregularities.Product analysis was unable to confirm the reported incorrect length.
 
Event Description
It was reported that the balloon length was shorter than expected.This ranger global dcb otw 6.0 x 60mm, 135cm was selected for use in a percutaneous angioplasty procedure.The lesion was in the superior femoral artery (sfa), was mildly calcified, had moderate tortuosity, and was 95 percent stenosed.During fluoroscopy during the procedure, it was suspected that the balloon length was 5.5cm instead of the expected 6cm.After the procedure the balloon length was measured outside the body and was 5.5cm.There was no patient injury.The device is expected to be returned.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
RANGER PACLITAXEL-COATED PTA BALLOON CATHETER
Type of Device
DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETER
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 Key16615993
MDR Text Key312009763
Report Number2124215-2023-10695
Device Sequence Number1
Product Code ONU
UDI-Device Identifier08714729976103
UDI-Public08714729976103
Combination Product (y/n)Y
Reporter Country CodeJA
PMA/PMN Number
P190019
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 04/24/2023
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 Date05/17/2024
Device Model Number1973-03
Device Catalogue Number1973-03
Device Lot Number04318H22
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/06/2023
Initial Date FDA Received03/24/2023
Supplement Dates Manufacturer Received04/07/2023
Supplement Dates FDA Received04/24/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/18/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
-
-