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

Model Number	VA8094
Medical Device Problem Codes	Deflation Problem (1149); Entrapment of Device (1212); Difficult to Remove (1528); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/04/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an angioplasty procedure, the pta balloon was allegedly stuck in a patient and wouldn¿t deflate all the way.It was further reported that the balloon was allegedly difficult to be removed.There was no reported patient injury.
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: 05/2025.
Event or Problem Description
It was reported that during an angioplasty procedure, the pta balloon allegedly got stuck in the patient.It was further reported that the balloon allegedly would not deflate.Reportedly, the balloon catheter was cut and removed along with the sheath as one unit.There was no reported patient injury.
Additional 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 vaccess pta dilatation was returned for evaluation in a partially detached catheter loaded in an unknown sheath.Bunching and stretching were also noted on the catheter shaft.The balloon had minor bunching, and there were kinks throughout the device.No other anomalies were noted during the visual evaluation.During functional testing, an attempt to remove the sheath was made but was unsuccessful.No further testing was performed due to the nature of the complaint.As a result of the investigation, it is confirmed that the reported catheter was difficult to remove from the sheath because it was loaded into an unknown sheath which returned for evaluation, where it was unable to be removed during functional testing.The investigation is also confirmed for the identified bunching and stretching of the catheter, as these anomalies were visible on the returned device.However, the investigation remains inconclusive for the reported deflation issue, as functional testing couldn¿t be performed due to the condition of the device returned for evaluation.The investigation also remains inconclusive for the reported balloon entrapment as the conditions of use couldn¿t be replicated under laboratory conditions.A definitive root cause for the reported difficult to remove from the sheath, identified bunching and stretching of the catheter, reported deflation issue and reported balloon entrapment 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.D4 (expiration date: 05/2025).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.

• 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: 16270098
• Report Number: 2020394-2023-00015
• Device Sequence Number: 7492185
• Product Code: LIT
• UDI-Device Identifier: 00801741121357
• UDI-Public: (01)00801741121357
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 02/21/2023

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: VA8094
• Device Catalogue Number: VA8094
• Device Lot Number: 93SG0044
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/04/2023
• Supplement Date Received by Manufacturer: 03/13/2023
• Initial Report FDA Received Date: 01/31/2023
• Supplement Report FDA Received Date: 03/21/2023
• 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: 70 YR
• Patient Sex: Unknown