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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. RIVAL PTA BALLOON DILATATION CATHETER

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BARD PERIPHERAL VASCULAR, INC. RIVAL PTA BALLOON DILATATION CATHETER Back to Search Results
Catalog Number RV8054
Device Problems Balloon (419); Retraction Problem (1536); Material Rupture (1546); Physical Resistance (2578)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 12/10/2015
Event Type  Malfunction  
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. 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 there was alleged resistance retracting the balloon through the sheath upon successful completion of the procedure. It was further reported that the health care provider allegedly observed a rupture after removing the balloon from the patient. There was no report of patient injury.

 
Manufacturer Narrative

Manufacturing review: a manufacturing review was conducted. The lot met all release criteria. Visual/microscopic inspection: the sample was returned used. The balloon size for this product is printed on the balloon hub of the catheter and identified the returned sample as a 5mm x 4cm balloon. A complete circumferential rupture was observed 76. 5cm from the strain relief. The device was returned in one piece as the inner lumen remained intact. The inner lumen was stretched, likely indicating that excessive force was used during retraction. The distal portion of the balloon was prolapsed over the distal tip, likely indicating retraction issues. Both marker bands were present on the catheter. No other anomalies were noted to the device. Functional/performance evaluation: an attempt was made to retract the balloon from the sheath; however, this was unsuccessful as the bunched distal portion of the balloon prevented this. No further functional testing could be performed due to the condition in which the sample was returned. Medical records review: as medical records were not provided, a review could not be performed. Image/photo review: no medical images have been made available to the manufacturer. Conclusion: based upon the conditions in which the device was returned, the investigation is confirmed for sheath retraction issues and a complete circumferential rupture. Per the reported event details, it was stated that the device was inflated with a syringe. The ifu (instructions for use) states that the use of a pressure monitoring device is recommended to prevent over pressurization. It is unknown whether the balloon was overpressurized or the use of a syringe contributed to the rupture. It is likely the rupture caused the balloon to bunch distally as it was being withdrawn from the sheath, resulting in the reported retraction issues. However, the definitive root cause for the balloon rupture could not be determined. It is unknown if patient and/or procedural issues contributed to the reported event. Labeling review: the current rival pta dilatation catheter instructions for use (ifu) provides general instructions for use of the device, as well as warnings, precautions, and potential complications associated with the device.

 
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Brand NameRIVAL 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)
C.R. BARD, INC. (GFO)
289 bay road
queensbury NY 12804
Manufacturer Contact
judith ludwig
1625 west 3rd st.
tempe, AZ 85281
4803032689
MDR Report Key5336889
MDR Text Key35211178
Report Number2020394-2015-02079
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK052149
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 12/10/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/30/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date08/31/2018
Device Catalogue NumberRV8054
Device LOT NumberGFZG2535
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer12/28/2015
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/24/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/19/2015
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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