MAUDE Adverse Event Report: TELEFLEX INCORPORATED ARROW INTRO 8F ARROW SHEATH; INTRODUCER, CATHETER

Model Number CL-07811

Device Problems Break (1069); Collapse (1099); Positioning Failure (1158)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/18/2023

Event Type  malfunction  

Event Description

Could not reposition the item correctly and the balloon pump was removed.Md pulled back on the iabp to reposition and was unable to get in correct position, md removed iabp and when removing iabp the 8f arrowflex sheath collapsed and snapped at the hub.Reinstalled this month.

• Brand Name: ARROW INTRO 8F ARROW SHEATH
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): TELEFLEX INCORPORATED; 3015 carrington mill blvd; morrisville NC 27560
• MDR Report Key: 17029930
• MDR Text Key: 316206723
• Report Number: 17029930
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 05/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: CL-07811
• Device Catalogue Number: CL-07811
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/23/2023
• Event Location: Hospital
• Date Report to Manufacturer: 05/31/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1