MAUDE Adverse Event Report: COVIDIEN LP ARGYLE; CATHETER, PERITONEAL, LONG-TERM INDWELLING

Model Number 8888413823

Device Problem Break (1069)

Patient Problem No Code Available (3191)

Event Date 05/11/2020

Event Type  malfunction  

Event Description

Argyle peritoneal dialysis catheter was implanted on female patient without any complications and patient released from hospital.Patient returned for follow-up visit on approximately two weeks later, and catheter wasn't flushing when regular heparin infused and noted contrast pooled in the subcutaneous tissue.Attempt to locate distal catheter end failed, and ct was ordered.Ct revealed that catheter was broken in two pieces.Patient was taken into surgery to have broken device removed.

• Brand Name: ARGYLE
• Type of Device: CATHETER, PERITONEAL, LONG-TERM INDWELLING
• Manufacturer (Section D): COVIDIEN LP; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 10113938
• MDR Text Key: 193645375
• Report Number: 10113938
• Device Sequence Number: 1
• Product Code: FJS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 8888413823
• Device Catalogue Number: 8888413823
• Device Lot Number: 1934400130
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/28/2020
• Event Location: Hospital
• Date Report to Manufacturer: 06/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 17155 DA