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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. TRUE DILATATION CATHETER; BALLOON VALVULOPLASTY CATHETER
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BARD PERIPHERAL VASCULAR, INC. TRUE DILATATION CATHETER; BALLOON VALVULOPLASTY CATHETER Back to Search Results
Catalog Number 0284514
Device Problems Break (1069); Difficult to Remove (1528); Material Rupture (1546); Detachment of Device or Device Component (2907)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 12/28/2023
Event Type  Injury  
Manufacturer Narrative
H10: as the lot number for the device was provided, a review of the device history records is currently being performed.The return of the sample is pending.The investigation of the reported event is currently underway.H10: d4 (expiration date: 07/2026).H11: section a through f ¿ the information provided by bd represents all 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 bd.
 
Event Description
It was reported that during a valvuloplasty procedure, the ptv balloon allegedly ruptured.It was further reported that the balloon allegedly detached and the physician was allegedly unable to pull the balloon out of the sheath.Reportedly, a right common femoral artery exploration was made for foreign body removal through the common femoral vein longitudinal venotomy, and primary repair of right common femoral vein venotomy was performed to remove device and repair vasculature.The current status of the patient is unknown.
 
Manufacturer Narrative
H10: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: the physical device was not returned for evaluation.No photos were provided for review.Therefore, the investigation is inconclusive for the reported failure as no objective evidence was provided for review.A definitive root cause for the reported balloon rupture, balloon break and sheath removal issue could not be determined based upon the provided information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H10: d4 (expiration date: 07/2026), g3, h6 (method).H11: h6 (device, result, conclusion).H11: section a through f ¿ the information provided by bd represents all 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 bd.
 
Event Description
It was reported that during a valvuloplasty procedure, the ptv balloon allegedly ruptured.It was further reported that the balloon allegedly detached and the physician was allegedly unable to pull the balloon out of the sheath.Reportedly, a right common femoral artery exploration was made for foreign body removal through the common femoral vein longitudinal venotomy, and primary repair of right common femoral vein venotomy was performed to remove device and repair vasculature.The current status of the patient is unknown.
 
Manufacturer Narrative
Manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: one true dilatation pta dilatation catheter was returned for evaluation.On the visual evaluation, the balloon had a break from the proximal end of the catheter, exposing the inner guide wire lumen and port hole and the balloon was still intact with the distal tip and to the catheter.No other anomalies were noted, and no functional testing could be performed due to the condition of the device.As the balloon had a break from the proximal end of the catheter which was still intact to catheter and no objective evidence of balloon rupture could be noted due to device condition and functional testing was also not performed.Hence, the investigation is confirmed for the reported break.However, the investigation remains inconclusive for the reported balloon rupture and sheath removal issue.A definitive root cause for the reported balloon rupture, balloon break and sheath removal issue could not be determined based upon the provided information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.(expiration date: 07/2026) section a through f ¿ the information provided by bd represents all 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 bd.
 
Event Description
It was reported that during a valvuloplasty procedure, the ptv balloon allegedly ruptured.It was further reported that the balloon allegedly detached from the catheter shaft but stayed attached at the tip which caused it to fold over itself and prevented removal from the vein.Furthermore, the physician was allegedly unable to pull the balloon out of the sheath.Reportedly, a right common femoral artery exploration was made for foreign body removal through the common femoral vein longitudinal venotomy, and primary repair of right common femoral vein venotomy was performed to remove the device and repair vasculature.The current status of the patient is unknown.
 
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Brand Name
TRUE DILATATION CATHETER
Type of Device
BALLOON VALVULOPLASTY CATHETER
Manufacturer (Section D)
BARD PERIPHERAL VASCULAR, INC.
1625 w 3rd st.
tempe AZ 85281
Manufacturer (Section G)
C.R. BARD, INC. (GFO)
289 bay road
queensbury 12804
Manufacturer Contact
brett curtice
800 w. rio salado pkwy
tempe, AZ 85281
4803032689
MDR Report Key18564074
MDR Text Key333482625
Report Number2020394-2024-00084
Device Sequence Number1
Product Code OZT
UDI-Device Identifier00801741097478
UDI-Public(01)00801741097478
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K150667
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Health Professional,User Facility,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 02/18/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/23/2024
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number0284514
Device Lot NumberGFHU0623
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/12/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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