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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 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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BARD PERIPHERAL VASCULAR, INC. CONQUEST 40 PTA BALLOON DILATATION CATHETER CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number CQF5084
Device Problem Material Rupture (1546)
Patient Problem Intimal Dissection (1333)
Event Date 08/24/2017
Event Type  Injury  
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. Conclusion: the device was returned for evaluation. A visual inspection did not find any rupture related defects with the balloon. However, an inflation attempt was made and a longitudinal rupture was identified on the barrel of the balloon. Therefore, the investigation is confirmed for a longitudinal rupture. The definitive root cause for the identified rupture could not be determined based upon the available information. It is unknown if patient and/or procedural issues contributed to the reported event. Labeling review: the current ifu (instructions for use) states: warnings: do not exceed the rbp recommended for this device. Balloon rupture may occur if the rbp rating is exceeded. To prevent over pressurization, use of a pressure monitoring device is recommended. (b)(4).
 
Event Description
It was reported that during an angioplasty procedure in the proximal basilic vein, the pta balloon allegedly ruptured on the first inflation attempt. The pta balloon was exchanged over the guidewire for another that was used to complete the procedure. Reportedly, a small vessel dissection occurred post balloon rupture. Patient was reported to be asymptomatic post procedure.
 
Manufacturer Narrative
No hospital/medical records or 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 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 proximal basilic vein, the pta balloon allegedly ruptured on the first inflation attempt. The pta balloon was exchanged over the guidewire for another that was used to complete the procedure. Reportedly, a small vessel dissection occurred post balloon rupture. Patient was reported to be asymptomatic post procedure.
 
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Brand NameCONQUEST 40 PTA BALLOON DILATATION CATHETER
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
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 Key6911881
MDR Text Key249780850
Report Number2020394-2017-01267
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 11/10/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/03/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/30/2020
Device Model NumberCQF5084
Device Catalogue NumberCQF5084
Device Lot NumberREBU0571
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/14/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/19/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/18/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 10/03/2017 Patient Sequence Number: 1
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