MAUDE Adverse Event Report: TELEFLEX INCORPORATED ARROW; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number IPN037783

Device Problems Difficult to Remove (1528); Unraveled Material (1664)

Patient Problem Death (1802)

Event Date 01/18/2018

Event Type  Death  

Event Description

During a cardiac resuscitation, doctor attempted central line placement in the pts rt femoral vein.When feeding guidewire, the wire unraveled in the patient.She had much difficulty removing from the patient.Patient required another femoral line to be placed in lt femoral vein.Reported to attending physician.

• Brand Name: ARROW
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): TELEFLEX INCORPORATED; 2400 bernville road; reading PA 19605
• MDR Report Key: 7236824
• MDR Text Key: 98859854
• Report Number: 7236824
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: IPN037783
• Device Catalogue Number: ASK-45703-PPHPB
• Device Lot Number: 23F17C0534
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/30/2018
• Event Location: Hospital
• Date Report to Manufacturer: 01/30/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 85 YR
• Patient Weight: 138