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

Model Number AT120204

Device Problems Deflation Problem (1149); Retraction Problem (1536)

Patient Problem Needle Stick/Puncture (2462)

Event Date 09/11/2019

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 device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.Medical device - expiry date: 11/2020.

Event Description

It was reported that during an angioplasty procedure in the superior vena cava via jugular vein, the pta balloon allegedly had deflation issues which additionally attributed to retraction problems.It was reported a femoral vein access was taken and a wire was introduced to snare the balloon externally.The balloon was moved down towards the femoral access.A needle was used to puncture the balloon and then being removed from the patient.It was further reported that the patient is medically stable.

Manufacturer Narrative

Manufacturing review: a lot history review was conducted and it was determined that a device history record (dhr) review was not required.Investigation summary: the device was returned for evaluation.A visual inspection was performed and the balloon was noted to be prolapsed over the distal tip.The outer catheter shaft was noted to be stretched proximally to the balloon glue joint.No other anomalies were noted to the device.As the user reported the balloon being punctured to deflate, no inflation attempt was made.The balloon fibers were stripped and the glue bullet was noted to be pulled away from the outer catheter shaft, no longer being seated in the correct position.No anomalies were noted to the device, inflation/deflation port.Therefore, the investigation is confirmed for the reported retraction issue, as stretching was noted to the device and the balloon was noted to be prolapsed over the distal tip.The investigation is inconclusive for the reported deflation issue, as no blockage of the inflation/deflation port was noted and no functional testing could be performed due to the condition of the device.Per the reported event details, the device was unable to be deflated.Therefore, the reported deflation issue may have led to the retraction issue.However, the definitive root cause for the reported deflation issue and retraction issue could not be determined based upon available information.It is unknown whether patient or procedural issues contributed to the event.               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.Additional mfr narrative: premarket identification.Device evaluated by mfr, adverse event problem, (results, conclusion).

Event Description

It was reported that during an angioplasty procedure in the superior vena cava via jugular vein, the pta balloon allegedly had deflation issues which additionally attributed to retraction problems.It was reported a femoral vein access was taken and a wire was introduced to snare the balloon externally.The balloon was moved down towards the femoral access.A needle was used to puncture the balloon and then being removed from the patient.It was further reported that the patient is medically stable.

• Brand Name: ATLAS 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: 9172935
• MDR Text Key: 161738901
• Report Number: 2020394-2019-03823
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00801741062728
• UDI-Public: (01)00801741062728
• Combination Product (y/n): N
• PMA/PMN Number: K120971
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 12/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AT120204
• Device Catalogue Number: AT120204
• Device Lot Number: GFBZ0214
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2019
• Date Manufacturer Received: 12/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 37 YR