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

Catalog Number VA80104

Device Problems Difficult to Insert (1316); Difficult to Remove (1528); Material Rupture (1546); Device-Device Incompatibility (2919); Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/31/2023

Event Type  malfunction  

Manufacturer Narrative

H10: 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.H10: d4 (expiry date: 03/2026).H11: 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.H3 other text : device not returned.

Event Description

It was reported that during an angioplasty procedure in the cephalic arch, the pta balloon allegedly ruptured at 15 atm and was only able to inflate to 10 atm prior to bursting.It was further reported that in an attempt to retrieve the balloon catheter, the balloon was unable to be retracted totally to allow passing through the sheath.Reportedly, the health care personnel proceeded to remove the sheath over the wire and then removed the balloon catheter.There was no reported patient injury.

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.The balloon was noted to be bunched near to the distal end.There were no other anomalies noted during the visual evaluation.On the functional testing, the balloon was inflated with an in-house presto inflation device and water was noted to be leaking from the balloon; upon further examination under microscope, a pin-hole balloon rupture was observed.Furthermore, the catheter was attempted to advance over the in-house guide wire which was inserted with slight resistance.Then, the catheter was attempted to insert into the in-house introducer sheath, but it was unsuccessful as strong resistance was observed.No other functional testing was performed.As the sample evaluation confirms, the pin-hole balloon rupture which was noted during the microscopic observation and during the visual evaluation, the balloon bunched was observed and during the functional testing the returned catheter was unable to pass through the introducer sheath as a strong resistance was felt.Therefore, the investigation is confirmed for reported balloon rupture and identified balloon bunching and catheter inability to pass through the introducer sheath.However, the investigation remains inconclusive for reported sheath removal issue as the functional testing couldn¿t be performed fully as the device was unable to insert into the sheath.A definitive root cause for the reported balloon rupture and sheath removal difficulty, identified balloon bunching and catheter inability to pass through the introducer sheath 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: 03/2026), g3, h6 (device).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 Description

It was reported that during an angioplasty procedure in the cephalic arch, the pta balloon allegedly ruptured at 15 atm and was only able to inflate to 10 atm prior to bursting.It was further reported that in an attempt to retrieve the balloon catheter, the balloon was unable to be retracted totally to allow passing through the sheath.Reportedly, the health care personnel proceeded to remove the sheath over the wire and then removed the balloon catheter.There was no reported patient injury.

• Brand Name: VACCESS
• Type of Device: 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: 17819020
• MDR Text Key: 324281855
• Report Number: 2020394-2023-00736
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 00801741121258
• UDI-Public: (01)00801741121258
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111850
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: VA80104
• Device Lot Number: 93QH0027
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/19/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Sex: Female
• Patient Weight: 52 KG
• Patient Race: Black Or African American