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

Catalog Number	VA8094
Medical Device Problem Codes	Difficult to Insert (1316); Difficult to Remove (1528); Material Rupture (1546); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an angioplasty procedure, the pta balloon allegedly had resistance inserting the sheath.It was further reported that the balloon allegedly had a hole and the contrast leaked out before it was fully inflated during the initial inflation.Reportedly, the sheath was allegedly stuck upon retrieval and there was significant resistance.The procedure was completed using another balloon.There was no reported patient injury.
Additional 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: 02/2027).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.
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 access catheter was returned for evaluation.No specific anomalies were noted during the visual evaluation.On the functional testing, the returned catheter was inflated with an in-house presto device and upon inflation the device leaks from the balloon.Upon microscopic observations, a longitudinal rupture was noted in the balloon.No other functional testing was performed.As the microscopic observations confirmed, the longitudinal balloon rupture and no further testing couldn¿t be performed due to device conditions.The investigation was confirmed for the reported balloon rupture and the investigation remains inconclusive for the reported sheath insertion failure and removal difficulties.A definitive root cause for the reported balloon rupture and sheath insertion failure and removal difficulties 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: 02/2027), g3.H11: h6 (method, 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 or Problem Description
It was reported that during an angioplasty procedure, the pta balloon allegedly had resistance inserting the sheath.It was further reported that the balloon allegedly had a hole and the contrast leaked out before it was fully inflated during the initial inflation.Reportedly, the sheath was allegedly stuck upon retrieval and there was significant resistance.The procedure was completed using another balloon.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: 19465922
• Report Number: 2020394-2024-00758
• Device Sequence Number: 7441689
• Product Code: LIT
• UDI-Device Identifier: 00801741121357
• UDI-Public: (01)00801741121357
• 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): 06/27/2024

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 Catalogue Number: VA8094
• Device Lot Number: 93PJ0066
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/09/2024
• Supplement Date Received by Manufacturer: 06/26/2024
• Initial Report FDA Received Date: 06/05/2024
• Supplement Report FDA Received Date: 07/12/2024
• 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