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

Model Number	VA8086
Medical Device Problem Codes	Deflation Problem (1149); Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/12/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.(expiration date: 08/2025).
Event or Problem Description
It was reported that during an angioplasty procedure, the pta balloon allegedly had deflation issue.It was further reported that the balloon was allegedly difficult to remove.The procedure was completed using another device.There was no reported patient injury.
Additional 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: one vaccess pta dilatation catheter was returned for evaluation.During visual examination, no specific anomalies were discovered.On functional testing, negative pressure was applied and the balloon was completely deflated; additionally, the catheter's inner guide wire lumen and the in-house sheath were flushed.Then, an in-house guide wire was inserted without any issue, and then the catheter was able to insert into the in-house sheath with resistance due to the device condition.Further, the balloon was inflated up to 8 atm and deflated within 9 seconds, which was within the acceptable limits of the product performance specification of the device.Then the balloon was able to retract through the sheath without any issue.No other functional testing was performed.Therefore, the investigation for the reported deflation problem is unconfirmed, as during functional testing the balloon was able to inflate and deflate without any issue, and the time taken for the deflation was also within the acceptable limit as per the product performance specification.The investigation is also unconfirmed for the reported removal difficulty through the sheath, as the returned catheter was able to insert and retract out through the in-house introducer sheath during functional testing.A definitive root cause for the reported deflation problem and removal difficulty through the sheath could not be determined based upon the provided information.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.H10: d4 (expiration date: 08/2025), g3, h6 (method).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 or Problem Description
It was reported that during an angioplasty procedure, the pta balloon allegedly failed to deflate fully.It was further reported that the balloon was allegedly difficult to remove through the sheath.The procedure was completed using another device.There was no reported patient injury.

• Brand Name: VACCESS PTA DILATATION CATHETER
• Common Device Name: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): FUTUREMATRIX INTERVENTIONAL; 1605 enterprise street; athens 75751
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 16110426
• Report Number: 2020394-2022-01049
• Device Sequence Number: 17852343
• Product Code: LIT
• UDI-Device Identifier: 00801741121340
• UDI-Public: (01)00801741121340
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K111850
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: VA8086
• Device Catalogue Number: VA8086
• Device Lot Number: 93VG0050
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/12/2022
• Supplement Date Received by Manufacturer: 03/28/2023
• Initial Report FDA Received Date: 01/06/2023
• Supplement Report FDA Received Date: 04/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Sex: Female
• Patient Race: Black Or African American