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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RANGER PACLITAXEL-COATED PTA BALLOON CATHETER; DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETER
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RANGER PACLITAXEL-COATED PTA BALLOON CATHETER; DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETER Back to Search Results
Model Number 1973-03
Medical Device Problem Code Material Rupture (1546)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 10/11/2021
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Initial reporter facility name: (b)(6).
 
Event or Problem Description
It was reported that the balloon ruptured.A 6.0 x 150mm, 90cm ranger drug-coated balloon was selected for use in a percutaneous transluminal angioplasty (pta) procedure in the left superficial femoral artery (sfa).The target lesion was 99% stenosed with moderate calcification and tortuosity.The balloon was inflated at 8 atm for 20 seconds during the first inflation at which point it ruptured.The balloon was removed.A new device was used to complete the procedure.There were no patient complications.
 
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Brand Name
RANGER PACLITAXEL-COATED PTA BALLOON CATHETER
Common Device Name
DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETER
MDR Report Key12662208
Report Number2134265-2021-12816
Device Sequence Number19886609
Product Code ONU
UDI-Device Identifier08714729976196
UDI-Public08714729976196
Combination Product (Y/N)Y
Initial Reporter CountryJA
PMA/510(K) Number
P190019
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 10/19/2021
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
Operator of Device Health Professional
Device Expiration Date01/23/2022
Device Model Number1973-03
Device Catalogue Number1973-03
Device Lot Number05089H20
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 10/12/2021
Initial Report FDA Received Date10/19/2021
Was Device Evaluated by Manufacturer? (Y/N) Device Not Returned to Manufacturer
Date Device Manufactured07/27/2020
Is the Device Labeled for Single Use? (Y/N) Yes
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Usage of Device Initial
Patient Sequence Number1
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