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

Catalog Number ATG80124

Device Problems Break (1069); Material Deformation (2976); Packaging Problem (3007)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/06/2018

Event Type  malfunction  

Manufacturer Narrative

No hospital/medical records or medical images have been made available to the manufacturer.A photo of the sample has been provided by the user facility.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 distal end of the inflation hub allegedly broke.Another balloon was used to complete the procedure.There was no reported patient injury.

Manufacturer Narrative

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.The device and one electronic photo were returned for evaluation.A visual inspection found the inflation luer of the hub to be deformed/flattened.Therefore, the investigation is confirmed for material deformation.No cracks of breaks were noted on the hub.Therefore, the investigation is unconfirmed for break.It is likely that the user perceived the deformed hub as a break.However, based on the photo review and physical packaging returned, the investigation is confirmed for a breach of the sterile barrier, as a tear/hole was seen in the tyvek side of the inner packaging sleeve.It should be noted that an imprint of the hub was seen in both the tyvek and clear plastic sides of the sleeve, indicating heat and force were applied at some point to the packaging containing the device.The tear in the tyvek packaging was at the location where the inflation luer of the hub would have been.Because the luer was deformed and misshapen, it is likely that a high amount of heat was applied to the packaging and device as no cracking was noted to the luer.Per the reported event details, the user facility did not steam sterilize the device prior to use.The sterilization records for the reported lot were reviewed.The lot was found to pass all sterility and ethylene oxide residual parameters.The lot met all required acceptance criteria at the time of lot release.Based on the available information the definitive root cause for the identified luer deformation or breach of the sterile barrier could not be determined.The review of the ifu (instructions for use), indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.

Event Description

It was reported that during an angioplasty procedure the distal end of the inflation hub allegedly broke.Another balloon was used to complete the procedure.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
• Manufacturer (Section G): FUTUREMATRIX INTERVENTIONAL; 1605 enterprise street; athens TX 75751
• Manufacturer Contact: judith ludwig ; 1625 w 3rd st.; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 7480081
• MDR Text Key: 107246248
• Report Number: 2020394-2018-00531
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 00801741060694
• UDI-Public: (01)00801741060694
• Combination Product (y/n): N
• Reporter Country Code: PO
• PMA/PMN Number: K122984
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/29/2020
• Device Catalogue Number: ATG80124
• Device Lot Number: 93WB0219
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/16/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/29/2017
• 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