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

Catalog Number IAB-S840C

Device Problems Leak/Splash (1354); Difficult to Advance (2920)

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

Event Date 07/25/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that during insertion of the intra-aortic balloon, the guidewire was not inserting properly when the balloon was connected to gas line, water was coming out.As a result, another balloon was successfully used.There was no delay/interruption in therapy.There was no reported death, serious injury or patient complications.No medical/surgical intervention was required.

Manufacturer Narrative

(b)(4).Teleflex did not receive the device for investigation therefore the reported complaint that the "guidewire was not inserting properly" is not able to be confirmed.The root cause of the complaint is undetermined.If the product is returned at a later date, a full investigation of the sample will be completed.No further action required.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.The reported complaint will be monitored for any developing trends.

Event Description

It was reported that during insertion of the intra-aortic balloon, the guidewire was not inserting properly when the balloon was connected to gas line, water was coming out.As a result, another balloon was successfully used.There was no delay/interruption in therapy.There was no reported death, serious injury or patient complications.No medical/surgical intervention was required.

Manufacturer Narrative

Qn# (b)(4).Teleflex did not receive the device for investigation therefore the reported complaint that the "guidewire was not inserting properly" is not able to be confirmed.The root cause of the complaint is undetermined.If the product is returned at a later date, a full investigation of the sample will be completed.No further action required.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.The reported complaint will be monitored for any developing trends.Other remarks: this complaint has been reopened to investigate the device that has been returned to teleflex for investigation.The reported complaint of iab tight over guidewire is confirmed.The guidewire was not able to fully advance through the central lumen due to a blockage of the central lumen at the bifurcate.The root cause of this complaint is unknown.This complaint is considered isolated, no other inner lumen blockages at the bifurcate site have been reported for this product.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 complaint.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 that during insertion of the intra-aortic balloon, the guidewire was not inserting properly when the balloon was connected to gas line, water was coming out.As a result, another balloon was successfully used.There was no delay/interruption in therapy.There was no reported death, serious injury or patient complications.No medical/surgical intervention was 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: 6826714
• MDR Text Key: 83862066
• Report Number: 1219856-2017-00194
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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,Followup
• Report Date: 08/04/2017

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: 03/31/2019
• Device Catalogue Number: IAB-S840C
• Device Lot Number: 18F17C0060
• Other Device ID Number: 00801902002679
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/04/2017
• Initial Date FDA Received: 08/29/2017
• Supplement Dates Manufacturer Received: 09/29/2017; 08/29/2018
• Supplement Dates FDA Received: 09/29/2017; 08/29/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/28/2017
• 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