MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. REDIGUARD IAB: 8FR 40CC; SYSTEM, BALLOON, INTRA-AORTIC

Catalog Number IAB-S840C

Device Problem Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/19/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported during intra-aortic balloon (iab) insertion on a patient the medical doctor tried to pass the guidewire through the catheter.However, the catheter could not be passed over the guidewire.The md could not proceed with the procedure.As a result, the medical doctor removed the device and replaced it with a new set successfully.There was no delay/interruption in therapy.No patient complications and no reported patient death or serious injury.No medical intervention required.

Manufacturer Narrative

(b)(4).Teleflex received the device for investigation.The reported complaint of iab tight over guidewire is confirmed.Upon return, the iab had a 0.025in guidewire partially inserted through the iab distal tip; the guidewire remained stuck in the central lumen.Upon further inspection, the location of resistance to the central lumen was found damaged with kinks and flattened features.The root cause of the damage to the central lumen is undetermined but a potential cause is a result of customer handling.A device history record (dhr) review was conducted for the lot number with no relevant findings.The device passed all manufacturing specifications prior to release.Teleflex assessed the risk for the reported device.There are no new or revised risks.This will be monitored for any developing trends.No further action required at this time.

Event Description

It was reported during intra-aortic balloon (iab) insertion on a patient the medical doctor tried to pass the guidewire through the catheter.However, the catheter could not be passed over the guidewire.The md could not proceed with the procedure.As a result, the md removed the device and replaced it with a new set successfully.There was no delay/interruption in therapy.No patient complications and no reported patient death or serious injury.No medical intervention required.

• Brand Name: REDIGUARD IAB: 8FR 40CC
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 16 elizabeth drive; chelmsford MA 01824
• Manufacturer Contact: carmen sherman ; 16 elizabeth drive; chelmsford, MA 01824 ; 9782505100
• MDR Report Key: 7279934
• MDR Text Key: 100473152
• Report Number: 2518433-2018-00007
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K981660
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2018
• Device Catalogue Number: IAB-S840C
• Device Lot Number: 18F16F0001
• Other Device ID Number: 00801902002679
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/21/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/01/2016
• 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