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

Model Number	AT120204
Medical Device Problem Codes	Deflation Problem (1149); Retraction Problem (1536)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	09/11/2019
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional 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 or Problem 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
• Common Device Name: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 9172935
• Report Number: 2020394-2019-03823
• Device Sequence Number: 2402299
• Product Code: DQY
• UDI-Device Identifier: 00801741062728
• UDI-Public: (01)00801741062728
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K120971
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Initial Date Received by Manufacturer: 09/12/2019
• Supplement Date Received by Manufacturer: 12/04/2019
• Initial Report FDA Received Date: 10/09/2019
• Supplement Report FDA Received Date: 12/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 37 YR