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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 Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/31/2022
Event Type  malfunction  
Event Description
It was reported that there was foreign material on the device.A 5.0mm x 200mm, 150cm ranger drug-coated balloon was selected for use in the superficial femoral artery.The 90% stenosed lesion was mildly calcified and located in moderately tortuous anatomy.Outside the patient after opening the package, the balloon was taken out of the hoop, and the guidewire was inserted from the tip of the balloon; however, the guidewire was inserted between the loading tool and balloon by mistake.The guidewire was pulled out, and a thread-like substance came along with it.The substance looked like a piece of plastic.The procedure was completed without replacing the device.No patient complications were reported.
 
Manufacturer Narrative
(b)(6).
 
Manufacturer Narrative
E1: (b)(6).Device eval by manufacturer: the device was not received for analysis; however, a tube approx.22.6 cm long was received for analysis.The piece of material received was whiteish in color, 22.6 cm long with what looked like one finished end and the other end appeared damaged with blood matter on it.The tube was hollow, and the outer diameter measured 0.0219.Based on the color of the tube in relation to the color of the ranger device catheter and loading tool, it does not appear to be part of the ranger device.Fourier transform infrared spectroscopy (ftir) testing found it to be most similar to nylon 12 polyamide.
 
Event Description
It was reported that there was foreign material on the device.A 5.0mm x 200mm, 150cm ranger drug-coated balloon was selected for use in the superficial femoral artery.The 90% stenosed lesion was mildly calcified and located in moderately tortuous anatomy.Outside the patient after opening the package, the balloon was taken out of the hoop, and the guidewire was inserted from the tip of the balloon; however, the guidewire was inserted between the loading tool and balloon by mistake.The guidewire was pulled out, and a thread-like substance came along with it.The substance looked like a piece of plastic.The procedure was completed without replacing the device.No patient complications were reported.It was further reported that a non-boston scientific 0.014in guidewire was used.
 
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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
two scimed place
maple grove MN 55311
Manufacturer (Section G)
HEMOTEQ AG
adenauerstrasse 15
wuerselen 52146
GM   52146
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key14274308
MDR Text Key290763784
Report Number2134265-2022-05021
Device Sequence Number1
Product Code ONU
UDI-Device Identifier08714729976042
UDI-Public08714729976042
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 Foreign,Health Professional,Company Representative,Distributor
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 06/09/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/04/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date07/14/2023
Device Model Number1973-03
Device Catalogue Number1973-03
Device Lot Number04457H21
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/26/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/19/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/14/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
0.014 INCH CENTURY COMMAND GUIDEWIRE
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