MAUDE Adverse Event Report: TELEFLEX INCORPORATED ARROW; INTRODUCER, CATHETER

Catalog Number ASK-21242-IMC

Device Problems Break (1069); Entrapment of Device (1212); Difficult to Remove (1528); Physical Resistance/Sticking (4012)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/25/2022

Event Type  malfunction  

Event Description

Patient with a pre-operative diagnosis including severe aortic stenosis, prior liver transplant and femoral-femoral bypass was admitted to the operating room for placement of a central line (arrowg+ard blue® mac¿ two-lumen central venous access).Surgeon felt guidewire resistance and had to manipulate the wire to get it out.Upon inspection of the guidewire, doctor suspected a piece broke off inside the patient.Doctor placed a new line and clinical staff continued with the planned procedure.After the procedure was finished, clinical staff looked with ultrasound and x-ray and determined a part of the wire was retained inside the patient.Doctors scrubbed in to search for the part of the wire.The surgery was prolonged about 3 hours.The piece was found, taken out and sent to pathology.

• Brand Name: ARROW
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): TELEFLEX INCORPORATED; po box 12600; durham NC 27709
• MDR Report Key: 13440479
• MDR Text Key: 284980160
• Report Number: 13440479
• Device Sequence Number: 1
• Product Code: DYB
• 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: 01/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ASK-21242-IMC
• Device Lot Number: 13F21G0099
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/31/2022
• Event Location: Hospital
• Date Report to Manufacturer: 02/03/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 28470 DA
• Patient Sex: Male
• Patient Weight: 81 KG