MAUDE Adverse Event Report: ARGON MEDICAL DEVICES SKATER ALL-PURPOSE DRAINAGE CATHETER LOCKING PIGTAIL 7FR X 25CM

Model Number 756507025

Device Problems Detachment of Device or Device Component (2907); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Failure of Implant (1924)

Event Date 05/07/2022

Event Type  malfunction  

Event Description

Use process: the product has been used for more than half a year and has good performance.At 15:00 on (b)(6) 2022, the patient underwent "percutaneous transhepatic bile duct drainage" under dsa-guided local anesthesia in the interventional catheterization laboratory.On (b)(6) 2022 02:00, the family found that the connection between the drainage tube and the external hard part was broken.Can not continue to use, report to the doctor, the doctor will immediately replace the drainage tube.

Manufacturer Narrative

Sample is unavailable for evaluation.Images were provided for investigation.A follow-up report will be provided once the images have been reviewed.

Manufacturer Narrative

A review of the manufacturing and inspection records for this lot was conducted, and no deviations and non-conformances were recorded.A review of photos from the customer was performed, drainage tube breakage from the drainage hub and the complaint was confirmed.A conclusive root cause could not be determined with the confidence.Customer provided the image found drainage tube breakage from the drainage hub, most likely hub not fully mold with the drainage tube during the manufacture process.However; without the sample very hard to evaluate drainage tube was breakage or fully separate from the drainage hub.The complaint was confirmed, but without the sample very hard to root cause of this issue, based on the picture, provided by customer, so no corrective action required at this times.If the sample is returned at a future date, this complaint may be reopened for further evaluation at that time.

Event Description

Use process: the product has been used for more than half a year and has good performance.At 15:00 on (b)(6) 2022, the patient underwent "percutaneous transhepatic bile duct drainage" under dsa-guided local anesthesia in the interventional catheterization laboratory.On (b)(6) 2022 02:00, the family found that the connection between the drainage tube and the external hard part was broken., can not continue to use, report to the doctor, the doctor will immediately replace the drainage tube.

• Brand Name: SKATER ALL-PURPOSE DRAINAGE CATHETER LOCKING PIGTAIL 7FR X 25CM
• Type of Device: SKATER
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 flat creek rd; athens TX 75751
• Manufacturer Contact: elnaz rahman ; 1445 flat creek rd; athens, TX 75751 ; 9036759321
• MDR Report Key: 14604444
• MDR Text Key: 296967484
• Report Number: 0001625425-2022-01016
• Device Sequence Number: 1
• Product Code: GBQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 756507025
• Device Lot Number: 11395390
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/27/2022
• Initial Date FDA Received: 06/06/2022
• Supplement Dates Manufacturer Received: 05/27/2022
• Supplement Dates FDA Received: 07/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other