• 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 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 BALLOON DILATATION CATHETER Back to Search Results
Catalog Number CQ7574
Device Problems Balloon (419); Burst Container or Vessel (1074); Material Rupture (1546)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 12/02/2015
Event Type  Malfunction  
Manufacturer Narrative

No device, no medical records, and no medical images have been made available to the manufacturer. As the lot number for the device was provided, a review of the device history records is currently being performed. 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 a pta balloon shaft allegedly ruptured at approximately 35 atm during the first inflation in an upper arm a/v graft. It was further reported that there was no difficulty retracting the balloon through the sheath. Reportedly, another pta balloon was used to complete the procedure. There was no patient injury reported.

 
Manufacturer Narrative

Manufacturing review: the lot number has been provided and the lot device history records have been reviewed. The 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 for this lot number and issue to date. Visual inspection: the sample was returned. A shaft burst was idientified on the catheter, located 10. 2cm from the distal tip. As a result of the burst, the polyimide was exposed underneath. No fiber disturbance was observed to the balloon. No other anomalies were observed to the device. Functional/performance evaluation: the patency of the guidewire lumen was tested using an in-house 0. 035¿ guidewire, and it passed without issue. No further functional testing could be performed due to the catheter shaft burst. Medical records review: medical records were not provided; therefore, a review could not be performed. Image/photo review: images/photos were not provided; therefore, a review could not be performed. Conclusion: based on these results, the investigation is confirmed for a catheter shaft burst. Per the reported event details, the catheter shaft burst at 35atm. The rated burst pressure (rbp) for this balloon size is 30atm; therefore, the balloon was over pressurized. It is likely that the overpressurization of the device contributed to the catheter shaft burst. Labeling review: the current ifu (instructions for use) states: warnings: do not exceed the rbp recommended for this device. Balloon rupture or difficulty in deflation may occur if the rbp rating is exceeded. To prevent over pressurization, use of a pressure monitoring device is recommended. Additionally, specific precautions and potential complications associated with the device are included in the ifu. Conquest pta dilatation catheter brochure: the rbp (rated burst pressure) for cq7574 is 30atm.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameCONQUEST PTA BALLOON DILATATION CATHETER
Type of DevicePTA BALLOON DILATATION CATHETER
Manufacturer (Section D)
BARD PERIPHERAL VASCULAR, INC.
1625 west 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 west 3rd st.
tempe, AZ 85281
4803032689
MDR Report Key5339099
MDR Text Key35257948
Report Number2020394-2015-02087
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK083657
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/09/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/31/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date06/30/2018
Device Catalogue NumberCQ7574
Device LOT NumberREZF0995
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer12/31/2015
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/09/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured07/16/2015
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-