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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. DORADO PTA BALLOON DILATATION CATHETER

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BARD PERIPHERAL VASCULAR, INC. DORADO PTA BALLOON DILATATION CATHETER Back to Search Results
Model Number DR80510
Device Problems Break (1069); Leak/Splash (1354)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/17/2022
Event Type  malfunction  
Event Description
It was reported that reported that during an angioplasty procedure in the superficial femoral artery via ipsilateral antegrade approach, the contrast medium allegedly leaked from the hub of the catheter. It was further reported that another device was used to complete the procedure. There was no reported patient injury.
 
Manufacturer Narrative
Manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot. Investigation summary: one dorado pta dilatation catheter was returned for evaluation. On visual evaluation of the device, no specific anomalies noted. Upon functional evaluation, the device was inflated with an in-house presto device to14 atm and water was noted to be leaking from the balloon bond joint to the catheter. Microscopic observation was performed and noted a circumferential break at the proximal glue joint. Therefore, the investigation has confirmed for the reported leak as the water leaks from the catheter bond joint to balloon during the functional testing. The investigation also confirmed for the identified break as a circumferential break at the proximal glue joint during the microscopic observation of the returned device for evaluation. During the microscopic observation a break was noted on the proximal glue joint on the catheter might contribute the reported leak. The definitive root cause could not be determined based upon available information. Labeling review: a review of product labeling documentation (e. G. , procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy. (expiry date: 07/2024).
 
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Brand NameDORADO
Type of DevicePTA BALLOON DILATATION CATHETER
Manufacturer (Section D)
BARD PERIPHERAL VASCULAR, INC.
1625 w 3rd st.
tempe AZ 85281
Manufacturer (Section G)
FUTUREMATRIX INTERVENTIONAL
1605 enterprise street
athens 75751
Manufacturer Contact
judy ludwig
800 w. rio salado pkwy
tempe, AZ 85281
4803032689
MDR Report Key13988339
MDR Text Key288519863
Report Number2020394-2022-00248
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K072283
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 03/31/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/02/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberDR80510
Device Catalogue NumberDR80510
Device Lot Number93UF0104
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/14/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/31/2022
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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