MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC REDIGUARD IAB: 7FR 30CC; SYSTEM, BALLOON, INTRA-AORTIC

Model Number IPN039779

Device Problem Material Twisted/Bent (2981)

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

Event Date 08/17/2022

Event Type  malfunction  

Event Description

It was reported that "the patient underwent cag, ptca with postoperative iabp support, the surgeon inserted the balloon, when the balloon was withdrawn from the box there was a slight kinked of the balloon, [the surgeon] tried to insert the balloon, the insert process was not smooth and could not be inserted, the balloon was withdrawn and replaced with a new balloon, the implantation was successful".Further information states that the second catheter was inserted at the same insertion site.The patient condition is reported as "fine".

Manufacturer Narrative

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

Event Description

It was reported that "the patient underwent cag, ptca with postoperative iabp support, the surgeon inserted the balloon, when the balloon was withdrawn from the box there was a slight kinked of the balloon, [the surgeon] tried to insert the balloon, the insert process was not smooth and could not be inserted, the balloon was withdrawn and replaced with a new balloon, the implantation was successful".Further information states that the second catheter was inserted at the same insertion site.The patient condition is reported as "fine".

Manufacturer Narrative

Qn# (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: REDIGUARD IAB: 7FR 30CC
• 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: 15815029
• MDR Text Key: 307679632
• Report Number: 3010532612-2022-00517
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10801902145632
• UDI-Public: 10801902145632
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K981660
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/10/2022

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 Expiration Date: 11/30/2023
• Device Model Number: IPN039779
• Device Catalogue Number: IAB-S730C
• Device Lot Number: 18F21M0002
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/10/2022
• Initial Date FDA Received: 11/17/2022
• Supplement Dates Manufacturer Received: 12/28/2022
• Supplement Dates FDA Received: 12/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2021
• 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
• Treatment: N/A.; N/A.
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 52 KG