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

Model Number IPN000263

Device Problems Break (1069); Difficult to Insert (1316)

Patient Problems No Consequences Or Impact To Patient (2199); Needle Stick/Puncture (2462)

Event Date 11/29/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the intra-aortic balloon (iab) tip was found cracked during insertion on the patient's right femoral artery, which cause insertion difficulty.As a result, a new iab kit was used to complete treatment at a new insertion site on the patient.There was no report of patient complications or death.

Event Description

It was reported that the intra-aortic balloon (iab) tip was found cracked during insertion on the patient's right femoral artery, which cause insertion difficulty.As a result, a new iab kit was used to complete treatment at a new insertion site on the patient.There was no report of patient complications or death.

Manufacturer Narrative

(b)(4).Teleflex received the device for investigation.The reported complaint iab insertion difficulty is confirmed.The one-way valve failed during functional testing.A failing one-way valve will result in difficulty of pulling and maintaining a vacuum on the iab bladder.If a vacuum of the bladder is not maintained, it can result in iab insertion difficulty.The iab bladder membrane passed dimensional and functional inspection.The root cause of the failing one-way valve is undetermined.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.A supplier corrective action request (scar) has been previously opened for one-way valve failures upon manufacturing assembly testing; however, this failure was noted with dried blood/debris inside the one-way valve.This will be monitored for any developing trends.Teleflex assessed the risk for the reported complaint.There are no new or revived risk.This will be monitored for any developing trends.

• Brand Name: REDIGUARD IAB: 8FR 40CC
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 9532357
• MDR Text Key: 173100677
• Report Number: 3010532612-2019-00458
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 00801902002679
• UDI-Public: 00801902002679
• Combination Product (y/n): N
• PMA/PMN Number: K981660
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 12/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2021
• Device Model Number: IPN000263
• Device Catalogue Number: IAB-S840C
• Device Lot Number: 18F19G0052
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2019
• Date Manufacturer Received: 01/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 54 YR
• Patient Weight: 50