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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. CONQUEST 40 PTA BALLOON DILATATION CATHETER

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BARD PERIPHERAL VASCULAR, INC. CONQUEST 40 PTA BALLOON DILATATION CATHETER Back to Search Results
Model Number CQF7586
Device Problems Deflation Problem (1149); Inflation Problem (1310)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/26/2021
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 conquest 40 pta dilatation catheter has been received for the evaluation. On the visual evaluation, the device appeared bloody and no other specific anomalies were noted. On the functional evaluation the balloon was inflated using an in house presto inflation device but it was only able to partially inflate. Additionally, balloon deflated with issues. On further balloon was cut and examined under magnification, the glue bullet was noted not to be seated in the correct position. No further testing was performed. Therefore the investigation for the reported inflation issue was confirmed as the balloon cannot fully inflated during the inflation using an in-house presto inflation device. The investigation for the identified deflation issue was also confirmed as the balloon deflated with issues during the evaluation. The pulled glue bullet noted during evaluation, most likely contributed to the reported inflation and deflation issues. However, the definitive root cause for the reported inflation issue and the identified deflation issue could not be determined based upon the provided 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: 03/2023).

 
Event Description

It was reported that during an angioplasty procedure, the pta balloon allegedly had an inflation issue. There was no reported patient injury.

 
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Brand NameCONQUEST 40
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 Key12194693
MDR Text Key262406237
Report Number2020394-2021-01353
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK120660
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 06/24/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/20/2021
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberCQF7586
Device Catalogue NumberCQF7586
Device LOT NumberREER2287
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer05/21/2021
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/22/2021
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: 07/20/2021 Patient Sequence Number: 1
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