MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ULTRAFLEX IAB: 7.5FR 40CC; SYSTEM, BALLOON, INTRA-AORTIC

Model Number IPN915322

Device Problem Defective Device (2588)

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

Event Date 02/22/2023

Event Type  malfunction  

Manufacturer Narrative

Qn#(b)(4).N/a.Other remarks: n/a.Corrected data: n/a.

Event Description

Reported as "sterile covering issue".It was reported that the sheath protector came off of the winged suture point or from the blue hub of the sheath.This is an axillary insertion.Once the sheath protector came off, it exposed the catheter and they had to take the patient back to the cath lab to replace the catheter.The pump was pumping without alarms, the balloon was functioning.This was just because the sheath protector came off of the connection.They also stated that the sheath protector was not stretched out tight there was some bunching of the sheath protector covering.There was no report of patient complications, serious injury or death.Patient status reported as "fine".

Event Description

Reported as "sterile covering issue".It was reported that the sheath protector came off of the winged suture point or from the blue hub of the sheath.This is an axillary insertion.Once the sheath protector came off, it exposed the catheter and they had to take the patient back to the cath lab to replace the catheter.The pump was pumping without alarms, the balloon was functioning.This was just because the sheath protector came off of the connection.They also stated that the sheath protector was not stretched out tight there was some bunching of the sheath protector covering.There was no report of patient complications, serious injury or death.Patient status reported as "fine".

Manufacturer Narrative

(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed, and no relevant findings were identified.Without the device to evaluate, the complaint could not be confirmed, and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.Other remarks: n/a.Corrected data: n/a.

• Brand Name: ULTRAFLEX IAB: 7.5FR 40CC
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 16 elizabeth drive; chelmsford MA 01824
• Manufacturer Contact: bryanna connelly ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 16555123
• MDR Text Key: 311699923
• Report Number: 3010532612-2023-00172
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10801902161946
• UDI-Public: 10801902161946
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K000729
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IPN915322
• Device Catalogue Number: IAB-06840-U
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/02/2023
• Initial Date FDA Received: 03/16/2023
• Supplement Dates Manufacturer Received: 04/21/2023
• Supplement Dates FDA Received: 04/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1