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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. CONQUEST PTA DILATATION CATHETER; PTA BALLOON DILATATION CATHETER
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BARD PERIPHERAL VASCULAR, INC. CONQUEST PTA DILATATION CATHETER; PTA BALLOON DILATATION CATHETER Back to Search Results
Model Number CQ7574
Device Problems Material Frayed (1262); Material Rupture (1546)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/22/2018
Event Type  malfunction  
Manufacturer Narrative
As the lot number for the device was provided, a review of the device history records is currently being performed.The return of the device is pending.The investigation of the reported event is currently underway.(expiry date 07/2021).
 
Event Description
It was reported that during an angioplasty procedure in the common iliac artery, the pta balloon allegedly ruptured.There was no reported patient injury.
 
Manufacturer Narrative
This supplemental emdr is being submitted to report a change in reportability, due to new information received on 1/21/2019.As the lot number for the device was provided, a review of the device history records is currently being performed.The return of the device is pending.The investigation of the reported event is currently underway.(expiry date 07/2021).
 
Event Description
It was reported that during an angioplasty procedure in the common iliac artery, the pta balloon allegedly ruptured.Another device was used to complete the procedure.There was no reported patient injury.
 
Event Description
It was reported that during an angioplasty procedure in the common iliac artery, the pta balloon allegedly ruptured.Another device was used to complete the procedure.There was no reported patient injury.
 
Manufacturer Narrative
This supplemental emdr is being submitted to report a change in lot number.The lot number was determined to be unknown on 2/15/2019.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.
 
Event Description
It was reported that during an angioplasty procedure in the common iliac artery, the pta balloon allegedly ruptured.Another device was used to complete the procedure.There was no reported patient injury.
 
Manufacturer Narrative
Manufacturing review: a complete manufacturing review could not be conducted, as the lot number was not reported for this device.Investigation summary: the device was returned for evaluation.A visual inspection found frayed fibers on the barrel of the balloon.Therefore, the investigation is confirmed for frayed fibers.The device was inflated and water was seen exiting the barrel of the balloon.The fibers were stripped away, and a pinhole rupture was noted in the balloon material.Therefore, the investigation is confirmed for a pinhole rupture.The definitive root cause for the identified frayed fibers or pinhole rupture could not be determined based upon the 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.
 
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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 Key8261734
MDR Text Key133558106
Report Number2020394-2018-02333
Device Sequence Number1
Product Code DQY
UDI-Device Identifier00801741062995
UDI-Public(01)00801741062995
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,foreig
Type of Report Initial,Followup,Followup,Followup
Report Date 03/29/2019
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 Model NumberCQ7574
Device Catalogue NumberCQ7574
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/30/2019
Initial Date Manufacturer Received 12/22/2018
Initial Date FDA Received01/18/2019
Supplement Dates Manufacturer Received01/21/2019
02/15/2019
03/15/2019
Supplement Dates FDA Received02/14/2019
02/19/2019
03/29/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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