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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. VACCESS PTA DILATATION CATHETER; PTA BALLOON DILATATION CATHETER
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BARD PERIPHERAL VASCULAR, INC. VACCESS PTA DILATATION CATHETER; PTA BALLOON DILATATION CATHETER Back to Search Results
Model Number VA8088
Device Problems Deflation Problem (1149); Retraction Problem (1536)
Patient Problem Injury (2348)
Event Date 04/18/2019
Event Type  Injury  
Manufacturer Narrative
The lot number for the device was provided.The device history records are currently under review.The facility rep stated that the device was available for evaluation.The return of the device is pending.The results of the anticipated device evaluation will be provided upon completion of the event investigation.
 
Event Description
It was reported that during a fistulagram with angioplasty, the pta balloon allegedly would not deflate completely.It was further reported that the balloon was stuck half way through the sheath.The heath care provider reportedly used an 18 gauge needle to puncture balloon in order to deflate completely.The balloon and sheath were removed together as one unit.The procedure was completed by placing a new sheath and pta balloon.There was no reported patient injury.
 
Manufacturer Narrative
Manufacturing review: a manufacturing review was conducted and there was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the device was returned for evaluation.A visual inspection found that the balloon was stuck in an unbranded sheath.The distal tip of the sheath was noted to be buckled, indicating retraction issues.Bunching was also noted to the balloon, which are consistent with retraction issues.In addition, stretching and kinking was noted to the catheter shaft near the proximal end of the balloon, also indicating retraction issues.Therefore, the investigation is confirmed for the identified retraction issues through the sheath.However, the investigation is inconclusive for the reported deflation issues as the balloon was unable to be functionally tested due to the balloon damage.Per the reported event details, it is likely that the deflation issue led to the retraction issues through the sheath.However, the definite root cause for the reported deflation issue and identified retraction issue could not be determined based upon 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.(expiration date: 01/2022).
 
Event Description
It was reported that during a fistulagram with angioplasty, the pta balloon allegedly would not deflate completely.It was further reported that the balloon was stuck half way through the sheath.The heath care provider reportedly used an 18 gauge needle to puncture balloon in order to deflate completely.The balloon and sheath were removed together as one unit.The procedure was completed by placing a new sheath and pta balloon.There was no reported patient injury.
 
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Brand Name
VACCESS 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 Key8560745
MDR Text Key143414909
Report Number2020394-2019-00528
Device Sequence Number1
Product Code DQY
UDI-Device Identifier00801741059971
UDI-Public(01)00801741059971
Combination Product (y/n)N
PMA/PMN Number
K111850
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Type of Report Initial,Followup
Report Date 11/14/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberVA8088
Device Catalogue NumberVA8088
Device Lot Number93ZC0092
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/29/2019
Initial Date Manufacturer Received 04/19/2019
Initial Date FDA Received04/29/2019
Supplement Dates Manufacturer Received11/13/2019
Supplement Dates FDA Received11/14/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age56 YR
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