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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 RV80615
Device Problems Difficult to Remove (1528); Retraction Problem (1536); Material Rupture (1546); Detachment of Device or Device Component (2907); Catheter (3038)
Patient Problems Ischemia (1942); Pseudoaneurysm (2605)
Event Date 01/12/2016
Event Type  Injury  
Manufacturer Narrative

No device, no medical records, or 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 device has not 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. Not returned.

 
Event Description

It was reported that the pta balloon catheter allegedly ruptured (atm unknown) in the sfa. It was further reported that the balloon catheter was allegedly difficult to remove through the sheath; therefore, the catheter, the sheath, and the guide wire were removed together as a single unit, resulting in loss of access to the lesion. The health care provider stated that the patient has a small pseudo aneurysm (location unknown) and will need to be rescheduled for another angioplasty procedure. There was no reported impact or consequence to the patient.

 
Manufacturer Narrative

Manufacturing review: a manufacturing review was conducted. The lot met all release criteria. Visual/microscopic inspection: the sample was returned. The balloon size for this product is printed on the balloon hub of the catheter and identified the returned sample as a 6mm x 15cm balloon. A 26. 2cm segment of the inner catheter was detached and returned on the guidewire. The inner catheter segment was stretched, indicating that excessive force had most likely been applied to the catheter during retraction. The balloon detachment occurred 67. 5cm from the strain relief. The edges of the balloon detachment were examined under microscopic magnification and indicates that the balloon likely ruptured circumferentially. The distal portion of the balloon was not returned for evaluation. Both marker bands were present on the returned catheter. Functional/performance evaluation: functional testing could not be performed due to the condition in which the sample was received. 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 condition in which the device was returned, the investigation is confirmed for retraction issues, a circumferential balloon rupture, a balloon detachment, and a catheter detachment. The definitive root cause for the balloon rupture could not be determined based upon available information. It is likely that the balloon rupture contributed to the inability to retract the balloon from the sheath and the balloon detachment. It is unknown whether patient and/or procedural issues contributed to the 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. (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.

 
Event Description

It was reported that the pta balloon catheter allegedly ruptured (atm unknown) in the sfa. It was further reported that the balloon catheter was allegedly difficult to remove through the sheath; therefore, the catheter, the sheath, and the guide wire were removed together as a single unit, resulting in loss of access to the lesion. The health care provider stated that the patient has a small pseudo aneurysm (location unknown). It was further reported that approximately one week post procedure, the patient presented with ischemic leg and surgical intervention was performed to retrieve the detached segment.

 
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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 Key5419058
MDR Text Key38343729
Report Number2020394-2016-00165
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeCA
PMA/PMN NumberK052149
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/14/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/09/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date03/31/2018
Device Catalogue NumberRV80615
Device LOT NumberGFZB2957
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/16/2016
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/06/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/24/2015
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: 02/09/2016 Patient Sequence Number: 1
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