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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
Catalog Number CQF5064
Device Problems Loss of or Failure to Bond (1068); Detachment of Device or Device Component (2907)
Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
Event Date 09/10/2015
Event Type  malfunction  
Manufacturer Narrative
No medical records or images have been made available to the manufacturer.The lot number for the device has been 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 the hub of the pta balloon dilatation catheter was allegedly detached from the catheter upon opening the package in the sterile field rendering it unusable.Reportedly, another pta balloon dilatation catheter was used to complete the procedure.There was no reported patient involvement.
 
Manufacturer Narrative
Manufacturing review: the lot number was provided and the lot device history records were 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 returned sample appeared to be clean.The balloon was in its original folded configuration with the stylet and balloon guard in place on the balloon.The guidewire hub was returned detached from the catheter.The guidewire hub was examined under microscopic magnification and it appeared that there was an insufficient amount of glue present at the glue fillet bond between the catheter and the guidewire hub.The proximal end of the catheter was examined under microscopic magnification and trace amounts of glue were present on the catheter at the location where it was bonded to the guidewire hub.Based on the amount of glue present on the catheter and the guidewire hub at the glue fillet bond, it appears that an insufficient amount of glue was applied.The glue fillet bond between the catheter and the inflation hub was intact and appeared to be a complete glue fillet.Functional/performance evaluation: no functional testing could be performed due to the condition of the returned sample (i.E.Hub detachment).Medical records & image/photo review: no medical records or images/photos were provided for review.Conclusion: the investigation is confirmed for a detached guidewire hub due to an insufficient amount of glue applied at the hub bond.The investigation is confirmed for a loss of bond between the catheter and guidewire hub.The root cause is manufacturing related as there was an insufficient amount of glue applied at the catheter to guidewire hub bond.This is the only complaint received for this issue to date, therefore, the complaint is an isolated event.Bard reynosa operator awareness training was performed regarding this complaint.Labeling review: specific warnings, precautions and directions for use of the dorado pta dilatation catheter are included in the current instructions for use (ifu).(b)(4).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.
 
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Brand Name
CONQUEST 40 PTA BALLOON DILATATION CATHETER
Type of Device
PTA 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 Key5131885
MDR Text Key28071690
Report Number2020394-2015-01674
Device Sequence Number1
Product Code DQY
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,health
Reporter Occupation Physician
Type of Report Followup
Report Date 09/10/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date05/31/2018
Device Catalogue NumberCQF5064
Device Lot NumberREZF0361
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/21/2015
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received10/07/2015
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received03/04/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/08/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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