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

Model Number	VA8084
Medical Device Problem Codes	Difficult to Remove (1528); Material Rupture (1546); Device-Device Incompatibility (2919); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was provided, a review of the device history record is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.(expiry date: 03/2024).
Event or Problem Description
It was reported that during the procedure, the balloon allegedly ruptured.It was further reported that the balloon was unable to be removed.The procedure was completed using another device.There was no reported patient injury.
Event or Problem Description
It was reported that during an angioplasty procedure, the balloon allegedly ruptured and was unable to be removed.It was further reported that the balloon allegedly got stuck inside the sheath.The procedure was completed using another device.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 catheter loaded with an unknown sheath was returned for evaluation.On the visual evaluation, the catheter noted stretched at the entry of the sheath and balloon noted to be stuck within the sheath, the distal end of the sheath noted to be buckled.The distal end of the balloon noted to be prolapsed.No other specific anomalies noted on the returned device.No functional testing performed due to the condition of the device returned for evaluation.Therefore, the investigation for the reported balloon rupture remains inconclusive as no functional testing performed due to the condition of the device returned for evaluation.The investigation for the reported difficult to advance and device-device incompatibility remains inconclusive as no functional testing performed due to the condition of the device returned for evaluation.However, the investigation for the reported difficult to remove was confirmed as the balloon noted to stuck and loaded into unknown sheath which returned for evaluation.A definitive root cause for the reported balloon rupture, difficult to advance and device-device incompatibility, difficult to remove 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.Section a through f - the information provided by bd represents all of 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: judy ludwig ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 12757396
• Report Number: 2020394-2021-01938
• Device Sequence Number: 19692818
• Product Code: LIT
• UDI-Device Identifier: 00801741121333
• UDI-Public: (01)00801741121333
• 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): 11/29/2021

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: VA8084
• Device Catalogue Number: VA8084
• Device Lot Number: 93QF0023
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/11/2021
• Supplement Date Received by Manufacturer: 11/29/2021
• Initial Report FDA Received Date: 11/07/2021
• Supplement Report FDA Received Date: 11/30/2021
• 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: 66 YR
• Patient Sex: Unknown
• Patient Weight: 103 KG