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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

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BOSTON SCIENTIFIC CORPORATION RANGER PACLITAXEL-COATED PTA BALLOON CATHETER; DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETER Back to Search Results
Model Number 1973-03
Device Problems Leak/Splash (1354); Material Rupture (1546)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/26/2023
Event Type  malfunction  
Event Description
It was reported that the balloon ruptured and had a pinhole.This 4.0 x 60mm, 80cm ranger paclitaxel-coated pta balloon catheter was selected for use in an endovascular therapy procedure.The 99% stenosed, moderately calcified, and moderately tortuous lesion was located in the right superficial femoral artery.The balloon ruptured and exhibited a pinhole slightly distal from the balloon catheter center.This was noted during the first inflation at 8 atm for approximately five seconds.The balloon was removed intact, and the procedure was completed with another of the same device.The physician noted this was effects of calcification.There were no patient complications.
 
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Brand Name
RANGER PACLITAXEL-COATED PTA BALLOON CATHETER
Type of Device
DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETER
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 Key17424155
MDR Text Key320158897
Report Number2124215-2023-40337
Device Sequence Number1
Product Code ONU
UDI-Device Identifier08714729975793
UDI-Public08714729975793
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,Distributor
Reporter Occupation Physician
Type of Report Initial
Report Date 07/31/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/31/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date08/27/2023
Device Model Number1973-03
Device Catalogue Number1973-03
Device Lot Number05417H21
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/27/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/27/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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