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

Model Number IPN000262

Device Problem Difficult to Insert (1316)

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

Event Date 10/21/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the front end of the intra-aortic balloon (iab) was too large.As a result, a new catheter was used, and another attempt was performed successfully.There was no report of patient death.Additional information received.It was reported that the second iab used the md changed site insertion from the right femoral artery to the left femoral artery.There was no report of patient complications.

Manufacturer Narrative

Qn#: (b)(4).Teleflex did not receive the device for investigation therefore the reported complaint of iab would not inflate completely is not able to be confirmed.The root cause of the complaint is undetermined.If the product is returned later, a full investigation of the sample will be completed.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.The reported complaint will be monitored for any developing trends.No further action required at this time.

Event Description

It was reported that the front end of the intra-aortic balloon (iab) was too large.As a result, a new catheter was used, and another attempt was performed successfully.There was no report of patient death.Additional information received.It was reported that the second iab used the md changed site insertion from the right femoral artery to the left femoral artery.There was no report of patient complications.

• Brand Name: REDIGUARD IAB: 7FR 30CC
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 9706645
• MDR Text Key: 179270707
• Report Number: 3010532612-2020-00051
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 00801902002686
• UDI-Public: 00801902002686
• 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: 01/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2021
• Device Model Number: IPN000262
• Device Catalogue Number: IAB-S730C
• Device Lot Number: 18F19H0012
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/22/2020
• Initial Date FDA Received: 02/13/2020
• Supplement Dates Manufacturer Received: 01/22/2020
• Supplement Dates FDA Received: 03/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1