Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. CONQUEST PTA DILATATION CATHETER; PTA BALLOON DILATATION CATHETER
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BARD PERIPHERAL VASCULAR, INC. CONQUEST PTA DILATATION CATHETER; PTA BALLOON DILATATION CATHETER Back to Search Results
Model Number CQ7584
Device Problems Material Frayed (1262); Retraction Problem (1536); Detachment of Device or Device Component (2907)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 09/11/2019
Event Type  Injury  
Manufacturer Narrative
As the lot number for the device was provided, a manufacturing review will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.(b)(4).
 
Event Description
It was reported that during an angioplasty procedure in the av fistula, the balloon allegedly detached from the catheter.It was further reported that the physician performed an angiography and the wrapping appeared to shear off of the balloon.The physician was able to access the other arm and snare the wrapping and pull it through an 11f sheath in the opposite arm.The event caused the access to clot; therefore, a declotting procedure was needed to obtain usage of the fistula.The device was removed during the same procedure.The patient is medically stable.
 
Event Description
It was reported that during an angioplasty procedure in the av fistula, the balloon allegedly detached from the catheter.It was further reported that the physician performed an angiography and the wrapping appeared to shear off of the balloon.The physician was able to access the other arm and snare the wrapping and pull it through an 11f sheath in the opposite arm.The event caused the access to clot; therefore, a declotting procedure was needed to obtain usage of the fistula.The device was removed during the same procedure.The patient is medically stable.
 
Manufacturer Narrative
Manufacturing review: a lot history review was conducted and it was determined that a device history record (dhr) review was not required.Investigation summary: the device was returned for evaluation.A visual inspection found that the balloon was detached from the device, with a portion of the inner guidewire lumen and distal marker band noted present within the balloon.Therefore, the investigation is confirmed for the reported balloon detachment.A visual inspection did not find any peeling to the balloon.Therefore, the investigation is unconfirmed for the reported balloon peeling.The balloon was returned detached from the device.As the conditions of use could not be fully recreated (e.G.Patient vessel), the investigation is h11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable inconclusive for the reported retraction issues through the sheath.Per the reported event details, it is likely that the reported retraction issues through the sheath led to the reported balloon detachment.However the definitive root cause for the reported balloon detachment or the reported retraction issues could not be determined based upon available information.Labeling review: the review of the ifu (instructions for use), indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.
 
Manufacturer Narrative
H10: manufacturing review: a lot history review was conducted and it was determined that a device history record (dhr) review was not required.Investigation summary: the device was returned for evaluation.A visual inspection found that the balloon was detached from the device, with a portion of the inner guidewire lumen and distal marker band noted present within the balloon.Therefore, the investigation is confirmed for the reported balloon detachment.A visual inspection did not find any peeling to the balloon.Therefore, the investigation is unconfirmed for the reported balloon peeling.The balloon was returned detached from the device.As the conditions of use could not be fully recreated (e.G.Patient vessel), the investigation is inconclusive for the reported retraction issues through the sheath.Per the reported event details, it is likely that the reported retraction issues through the sheath led to the reported balloon detachment.However the definitive root cause for the reported balloon detachment or the reported retraction issues could not be determined based upon available information.Labeling review: the review of the ifu (instructions for use), indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.H11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
 
Event Description
It was reported that during an angioplasty procedure in the av fistula, the balloon allegedly detached from the catheter.It was further reported that the physician performed an angiography and the wrapping appeared to shear off of the balloon.The physician was able to access the other arm and snare the wrapping and pull it through an 11f sheath in the opposite arm.The event caused the access to clot; therefore, a declotting procedure was needed to obtain usage of the fistula.The device was removed during the same procedure.The patient is medically stable.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
CONQUEST PTA DILATATION CATHETER
Type of Device
PTA BALLOON DILATATION CATHETER
Manufacturer (Section D)
BARD PERIPHERAL VASCULAR, INC.
1625 w 3rd st.
tempe AZ 85281
MDR Report Key9182531
MDR Text Key162315955
Report Number2020394-2019-03822
Device Sequence Number1
Product Code DQY
UDI-Device Identifier00801741063114
UDI-Public(01)00801741063114
Combination Product (y/n)N
PMA/PMN Number
K083657
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup,Followup
Report Date 02/26/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/11/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/31/2022
Device Model NumberCQ7584
Device Catalogue NumberCQ5084
Device Lot NumberREDP2877
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/18/2019
Date Manufacturer Received02/26/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Weight95
-
-