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

Catalog Number UNK VACCESS

Device Problem Material Rupture (1546)

Patient Problem Injury (2348)

Event Date 08/29/2020

Event Type  Injury  

Manufacturer Narrative

As the lot number for the device was not provided, a review of the device history records could not be performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.

Event Description

It was reported that during a pta procedure, the device allegedly ruptured.It was further noted that the patient allegedly experienced vessel trauma due to the rupture.The current status of the patient is unknown.

Event Description

It was reported that during an angioplasty procedure through left upper arm avf, the pta balloon allegedly ruptured at 24atm.It was further noted that the patient allegedly experienced vessel trauma due to the rupture.The current patient status is unknown.

Manufacturer Narrative

H10: manufacturing review:a complete manufacturing review could not be conducted, as the lot number was not reported for this device.Investigation summary:the device was returned for evaluation.The sample appeared to be bloody and no anomalies were noted to the device.The balloon was noted to have a longitudinal rupture exceeding 4.5cm approximately 2.5cm from the distal tip.No functional testing was conducted due to the condition of the device.Therefore, the investigation is confirmed for the reported balloon rupture.However, the definitive root cause for the reported balloon rupture could not be determined based upon available information.Labeling review:the review of the ifu (instructions for use), indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.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.

• Brand Name: VACCESS PTA DILATATION CATHETER
• Type of Device: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 10789357
• MDR Text Key: 214749031
• Report Number: 2020394-2020-06394
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• PMA/PMN Number: K111850
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 12/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK VACCESS
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2020
• Date Manufacturer Received: 12/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other