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U.S. Department of Health and Human Services

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

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BARD PERIPHERAL VASCULAR, INC. CONQUEST PTA DILATATION CATHETER PTA BALLOON DILATATION CATHETER Back to Search Results
Model Number CQ7594
Device Problems Deflation Problem (1149); Inflation Problem (1310)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/02/2021
Event Type  malfunction  
Manufacturer Narrative
Manufacturing review: a complaint history review was performed. This is the first complaint reported to date for this product and lot, therefore a device history record review is not required. Investigation summary: one conquest pta device was returned for evaluation. The sample was bloody, no kinks noted to the catheter. Functional evaluation was performed, the device guidewire lumen was flushed. The balloon was inflated using an in-house presto inflation device. The balloon was able to hold pressure and shape. It was noted that the deflation was slow, the balloon did not fully deflate. The balloon was cut and under microscopic evaluation it was noted that the glue bullet was not seated properly and inflation port holes were noted to be collapsed. Therefore, the investigation is confirmed for the identified deflation issue as the glue bullet was not seated properly. The investigation is also confirmed for the inflation issue as collapsed port holes were noted. A definitive root cause could not be determined based upon available information. Labeling review: the review of the instructions for use, indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate. (expiry date: 09/2023).
 
Event Description
It was reported that during a procedure through the left arm, the balloon was allegedly unable to inflate after several attempts. The procedure was completed using another device. There was no reported patient injury.
 
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Brand NameCONQUEST PTA DILATATION CATHETER
Type of DevicePTA BALLOON DILATATION CATHETER
Manufacturer (Section D)
BARD PERIPHERAL VASCULAR, INC.
1625 w 3rd st.
tempe AZ 85281
Manufacturer (Section G)
BARD REYNOSA S.A. DE C.V. -9617592
blvd. montebello #1
parque industrial colonial
reynosa, tamaulipas 88780
MX 88780
Manufacturer Contact
judy ludwig
800 w. rio salado pkwy
tempe, AZ 85281
4803032689
MDR Report Key11714693
MDR Text Key247012561
Report Number2020394-2021-00905
Device Sequence Number1
Product Code DQY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K083657
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 03/31/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/23/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberCQ7594
Device Catalogue NumberCQ7594
Device Lot NumberREEX0952
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/26/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/30/2021
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

Patient Treatment Data
Date Received: 04/23/2021 Patient Sequence Number: 1
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