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

Model Number ATG80144

Device Problems Migration or Expulsion of Device (1395); Material Separation (1562); Detachment of Device or Device Component (2907)

Patient Problem Injury (2348)

Event Date 06/11/2020

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 not been returned to the manufacturer for evaluation, however photo was provided for review.The investigation of the reported event is currently underway.(expiration date: 10/2022).

Event Description

It was reported that during an angioplasty procedure through popliteal artery, the pta balloon allegedly detached from the catheter and migrated into the left pulmonary artery while removal.Reportedly the balloon was retrieved via snare on the next day.The patient status was unknown.

Event Description

It was reported that during an angioplasty procedure through popliteal artery, the pta balloon allegedly detached from the catheter and migrated into the left pulmonary artery while removal.Reportedly the balloon was retrieved via snare on the next day.The patient status was unknown.

Manufacturer Narrative

H10: 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 not returned for evaluation; however, two photos were provided for review.The first photo shows the visible label of the device that matches the reported information.The second photo shows detached balloon which is bloody contained in a sealed bowl.No other anomalies was found from the submitted photo.Based on the photo review, the reported balloon detachment has confirmed.The definitive root cause for the reported balloon detachment 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.H10: d4 (expiration date: 10/2022).

• Brand Name: ATLAS GOLD PTA DILATATION CATHETER
• Type of Device: PTA DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 10238157
• MDR Text Key: 197733822
• Report Number: 2020394-2020-04299
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00801741060755
• UDI-Public: (01)00801741060755
• Combination Product (y/n): N
• PMA/PMN Number: K181323
• 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: 10/01/2020

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
• Device Operator: Health Professional
• Device Model Number: ATG80144
• Device Catalogue Number: ATG80144
• Device Lot Number: 93XD0182
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/16/2020
• Initial Date FDA Received: 07/07/2020
• Supplement Dates Manufacturer Received: 09/24/2020
• Supplement Dates FDA Received: 10/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention