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

Model Number ATG120142

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/02/2018

Event Type  malfunction  

Manufacturer Narrative

No hospital/medical records or medical images have been made available to the manufacturer.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.The information provided by bard 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 bard.

Event Description

It was reported that during an angioplasty procedure, the marker bands of the pta balloon were allegedly dislocated.There was no reported patient injury.

Manufacturer Narrative

H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.This is the only complaint reported to date for this lot number and failure mode.Investigation summary: the device was returned for evaluation.A visual inspection did not initially find any issues with the balloon.However, the balloon was examined under x-ray imaging and the marker bands were noted to be dislodged.The balloon was cut open to expose the marker bands and the inner guidewire lumen.No swage marks were noted to the marker bands or to the inner lumen.Both marker bands were able to slide easily on the guidewire lumen.Therefore, the investigation is confirmed for the reported dislodged marker bands.Based on the returned sample condition, it was found that the marker bands were not swaged to the inner guidewire lumen.Therefore, the root cause for the dislodged marker bands was found to be manufacturing-related.However, the definitive root cause for the missed swaging step during assembly could not be determined based on the available information.A supplier corrective action request was issued to the manufacturer of the device to address the issue.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.H10: d4 (expiry date: 09/2020).

Event Description

It was reported that during an angioplasty procedure, the marker bands of the pta balloon were allegedly dislocated.There was no reported patient injury.

• Brand Name: ATLAS GOLD 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: 7835666
• MDR Text Key: 118884324
• Report Number: 2020394-2018-01619
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 00801741060748
• UDI-Public: (01)00801741060748
• Combination Product (y/n): N
• PMA/PMN Number: K122984
• 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: 04/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/14/2020
• Device Model Number: ATG120142
• Device Catalogue Number: ATG120142
• Device Lot Number: 93WB0171
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2018
• Date Manufacturer Received: 03/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 15 YR