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

Model Number	VA8064
Medical Device Problem Codes	Material Puncture/Hole (1504); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/31/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was provided, a review of the device history records will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.(expiration date: 06/2025).
Event or Problem Description
It was reported that during an angioplasty procedure, the balloon was inflated and the pta balloon catheter allegedly had small hole at the proximal portion of the shaft where the diluted contrast allegedly leaked.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 dilatation catheter was returned for evaluation.No specific anomalies were noted during the visual evaluation.During the functional testing, negative pressure was applied to deflate the balloon completely.Then the catheter guide wire lumen and in-house introducer sheath were flushed.By using the in-house guide wire the catheter was passed through it without any issue, the balloon was inserted through the sheath and inflated with the in-house presto.Pin hole rupture was noted on the catheter shaft proximally near strain relief.Under the microscopic observation a tear was noted to the catheter shaft.Balloon was retracted with no issues.No other functional testing was performed.Therefore the investigation was confirmed for the reported catheter shaft puncture and identified tear, as a pin-hole tear was noted on the catheter shaft upon inflating the balloon, the anomaly was also confirmed under microscopic observation.A definitive root cause for the reported catheter shaft puncture and identified tear 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: 06/2025).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 balloon was inflated and the pta balloon catheter allegedly had small hole at the proximal portion of the shaft where the diluted contrast allegedly leaked.The procedure was completed using another device.There was no reported patient injury.

• Brand Name: VACCESS
• 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: 16483362
• Report Number: 2020394-2023-00132
• Device Sequence Number: 5263396
• Product Code: LIT
• UDI-Device Identifier: 00801741121296
• UDI-Public: (01)00801741121296
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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): 03/31/2023

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: VA8064
• Device Catalogue Number: VA8064
• Device Lot Number: 93TG0073
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/07/2023
• Supplement Date Received by Manufacturer: 03/31/2023
• Initial Report FDA Received Date: 03/04/2023
• Supplement Report FDA Received Date: 04/18/2023
• 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 Sex: Unknown