MAUDE Adverse Event Report: TELEFLEX INCORPORATED ARROW; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Lot Number 18F18L0011

Device Problems Difficult to Remove (1528); Failure to Advance (2524); Physical Resistance/Sticking (4012)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/31/2020

Event Type  malfunction  

Event Description

Called to bedside by rn for report of debris within the helium supply line.Black dots seen inside helium tubing (definitely on inside of tubing; could not remove from external catheter with alcohol swab) concerning for blood from balloon puncture.Iabp device was not alarming and pt's hemodynamics not affected at the time of event.Dr notified immediately.Iabp dropped to 1:4 and later to off with plan to exchange balloon emergently.Attempted left iabp removal with sheath over long guidewire with the intention of replacing sheath and iabp on this side but resistance met with removal of iabp/sheath unit with distal third of balloon still in the femoral vessel.This was ultimately removed by dr.And new sheath could not be advanced in this site, so manual pressure was held by staff while a new iabp was placed in the right femoral artery.

• Brand Name: ARROW
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): TELEFLEX INCORPORATED; po box 12600; durham NC 27709
• MDR Report Key: 10430522
• MDR Text Key: 203655781
• Report Number: 10430522
• Device Sequence Number: 1
• Product Code: DSP
• 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: 08/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: 18F18L0011
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/05/2020
• Event Location: Hospital
• Date Report to Manufacturer: 08/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 24820 DA