• 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 40 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 40 PTA DILATATION CATHETER PTA BALLOON DILATATION CATHETER Back to Search Results
Model Number CQF7588
Device Problems Device Packaging Compromised (2916); Packaging Problem (3007)
Patient Problem No Patient Involvement (2645)
Event Date 11/15/2017
Event Type  malfunction  
Manufacturer Narrative
The device history records were reviewed with special attention to the raw materials, subassemblies, manufacturing process and quality control testing. This lot met all release criteria. There was nothing found to indicate there was a manufacturing related cause for this event. This is the only complaint reported to date for this lot number and failure mode. The device was not returned, however one electronic photo was provided for review. Although a tear can be seen in the provided photo, it is unknown if a breach of the sterile barrier occurred as it cannot be verified if the sleeve shown has been opened. Additionally, the outer packaging is not visible, and cannot be reviewed for similar damage. Therefore, the investigation can be confirmed for a hole in the inner packaging sleeve. However, the investigation remains inconclusive for a breach of sterile barrier. It is unlikely that the root cause is manufacturing related as all packaged product manufactured is 100% verified for package integrity prior to shipment per spec. It is possible that shipping/handling or user related issues in opening the product packaging contributed to the event. However, the definitive root cause for the identified hole in the packaging sleeve could not be determined based upon the available information. Labeling review: the current instructions for use (ifu) states: warnings: contents supplied sterile using ethylene oxide (eo). Non-pyrogenic. Do not use if sterile barrier is opened or damaged. Single patient use only. Do not reuse, reprocess or re-sterilize. Precautions: carefully inspect the catheter prior to use to verify that catheter has not been damaged during shipment and that its size, shape and condition are suitable for the procedure for which it is to be used. Do not use if product damage is evident.
 
Event Description
It was reported that during preparation for an angioplasty procedure, a hole was found in the inner packaging sleeve. Another balloon was used to perform the procedure. There was no patient contact.
 
Manufacturer Narrative
No device, no medical records, or no medical images were provided to the manufacturer. The lot number for the device was provided. The device history records are currently under review. The investigation of the reported event is currently underway. The information provided by bard 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 bard.
 
Event Description
It was reported that during preparation for an angioplasty procedure, a hole was found in the inner packaging sleeve. Another balloon was used to perform the procedure. There was no patient contact.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameCONQUEST 40 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.
blvd montebello #1
parque industrial colonial
reynosa tamaulipas 88780
MX 88780
Manufacturer Contact
judith ludwig
1625 w 3rd st.
tempe, AZ 85281
4803032689
MDR Report Key7121576
MDR Text Key269723520
Report Number2020394-2017-01758
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K120660
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/01/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/15/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/30/2020
Device Model NumberCQF7588
Device Catalogue NumberCQF7588
Device Lot NumberREBX0481
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/29/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/25/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-