MAUDE Adverse Event Report: TELEFLEX INCORPORATED ARROW TEMPORARY PACING CATHETER; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Device Problem Output Problem (3005)

Patient Problem Insufficient Information (4580)

Event Date 03/31/2022

Event Type  malfunction  

Event Description

Sheath "condom" noticed to be filling with blood and "keep vein open" (kvo) fluids linked to cordis.

• Brand Name: ARROW TEMPORARY PACING CATHETER
• Type of Device: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): TELEFLEX INCORPORATED; po box 12600; durham NC 27709
• MDR Report Key: 14117538
• MDR Text Key: 289338775
• Report Number: 14117538
• Device Sequence Number: 1
• Product Code: DRF
• 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: 04/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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: 04/04/2022
• Event Location: Hospital
• Date Report to Manufacturer: 04/15/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 23725 DA
• Patient Sex: Female
• Patient Weight: 79 KG