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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 DR13564
Device Problems Break (1069); Leak/Splash (1354); Material Puncture/Hole (1504)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/09/2021
Event Type  malfunction  
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 has been received for the evaluation. On the visual evaluation, the device was noted bloody. No other specific anomalies were noted. On the functional evaluation, the balloon was inflated using an in-house presto inflation device and water was noted to be leaking from the distal tip. The device was examined under the microscopic observation and a circumferential break was noted at the glue joint. Then the balloon was cut and noted a hole at the proximal end of the guidewire lumen. No other functional testing performed. Therefore the investigation for the reported leak was confirmed as the water starts leaking from the circumferential break at proximal glue joint of the balloon upon inflation. The investigation for identified break was confirmed as the circumferential break was noted at proximal glue joint of the balloon under the microscopic observation. The investigation for the identified guidewire lumen hole was confirmed as the hole was noted at the inner guidewire lumen at proximal end of the balloon under the microscopic observation. The identified break at proximal glue joint of the balloon and the guidewire lumen hole are likely the root cause for the reported leak. However a definitive root cause for the reported leak and the identified break, guidewire lumen hole could not be determined based upon the provided 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: 11/2023).
 
Event Description
It was reported that during an angioplasty procedure, the pta balloon allegedly leaked at the proximal end. There was no reported patient injury.
 
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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 Key12486076
MDR Text Key271878856
Report Number2020394-2021-01717
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K072283
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 08/23/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/17/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberDR13564
Device Catalogue NumberDR13564
Device Lot Number93YE0093
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/18/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/21/2021
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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