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

Model Number VA8094

Device Problems Deflation Problem (1149); Peeled/Delaminated (1454)

Patient Problems Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/04/2021

Event Type  Injury  

Manufacturer Narrative

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.(expiry date: 06/2024).Device pending return.

Event Description

It was reported that during an angioplasty procedure, the pta balloon allegedly failed to deflate.It was further reported that the balloon flared when trying to remove.There was no patient injury.

Manufacturer Narrative

H10: manufacturing review: a manufacturing review was conducted and there was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the device was not returned for evaluation.Therefore, the investigation is inconclusive for the reported deflation problem and material peeling/delamination.The definitive root cause for the reported deflation problem and material peeling/delamination could not be determined based upon available 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 (expiry date: 06/2024),.

Event Description

It was reported that during an angioplasty procedure, the pta balloon allegedly failed to deflate.It was further reported that the balloon flared when trying to remove.There was no reported patient injury.

Event Description

It was reported that during an angioplasty procedure, the pta balloon allegedly failed to deflate.It was further reported that while removing the damaged sheath and partially deflated balloon, there was additional damage to the vessel creating larger hole as a result of cannulation.The procedure was completed using another device.The patient current status was unknown.

Manufacturer Narrative

H10: manufacturing review: a manufacturing review was conducted and there was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the device was not returned for evaluation.The investigation is inconclusive for the reported deflation problem.The definitive root cause for the reported deflation problem could not be determined based upon available 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 (expiry date: 06/2024), g3.H11: b5, h1, h6 (patient).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.

• 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: judy ludwig ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 12392508
• MDR Text Key: 268956451
• Report Number: 2020394-2021-01546
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 00801741121357
• UDI-Public: (01)00801741121357
• 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,Followup
• Report Date: 11/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VA8094
• Device Catalogue Number: VA8094
• Device Lot Number: 93TF0107
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/22/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/24/2021
• 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 Outcome(s): Required Intervention