MAUDE Adverse Event Report: ARGON MEDICAL DEVICES SKATER BILIARY DRAINAGE CATHETER LOCKING PIGTAIL

Model Number	8FR X 40 CM
Health Effect - Clinical Code	Malaise (2359)
Date of Event	12/23/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sample is indicated as available for evaluation.As of the date of this report, it has not yet been returned.A follow-up report will be provided once the sample has been received and reviewed.
Event or Problem Description
The patient was monitored because he was not feeling well, and it was observed in the angiographic control that the catheter had fragmented just in the area of the radiopaque mark.
Additional Manufacturer Narrative
H3 other text: placeholder.
Event or Problem Description
Follow up.
Additional Manufacturer Narrative
H3 other text: placeholder.

• Brand Name: SKATER BILIARY DRAINAGE CATHETER LOCKING PIGTAIL
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 flat creek rd; athens TX
• MDR Report Key: 11276547
• Report Number: 1625425-2021-00839
• Device Sequence Number: 14233237
• Product Code: FGE
• UDI-Device Identifier: 00886333006113
• UDI-Public: 00886333006113
• Combination Product (Y/N): N
• PMA/510(K) Number: K073672
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/03/2021

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 Expiration Date: 02/26/2025
• Device Model Number: 8FR X 40 CM
• Device Catalogue Number: 755308040
• Device Lot Number: 11298342
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 02/03/2021
• Supplement Report FDA Received Date: 03/19/2021; 04/09/2021
• 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: Other