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

Model Number IPN000263

Device Problem Material Puncture/Hole (1504)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/09/2020

Event Type  malfunction  

Manufacturer Narrative

Qn#: (b)(4).

Event Description

It was reported that the intra-aortic balloon (iab) ruptured during use on a patient.As a result, the iab was removed and a second iab was inserted at the same insertion site.There was no report of patient complications, serious injury or death.

Event Description

It was reported that the intra-aortic balloon (iab) ruptured during use on a patient.As a result, the iab was removed and a second iab was inserted at the same insertion site.There was no report of patient complications, serious injury or death.

Manufacturer Narrative

Qn# (b)(4).No part has returned to teleflex chelmsford for investigation.The reported complaint that the "iab catheter ruptured during use on a patient" is not able to be confirmed.If the product is returned at a later date, a full investigation of the sample will be completed.The root cause of the complaint 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.Teleflex assessed the risk for the reported complaint.There are no new or revived risk.This will be monitored for any developing trends.

Event Description

It was reported that the intra-aortic balloon (iab) ruptured during use on a patient.As a result, the iab was removed and a second iab was inserted at the same insertion site.There was no report of patient complications, serious injury or death.

Manufacturer Narrative

Qn#: (b)(4).Teleflex received the device for investigation.The reported complaint of iab leak suspected is confirmed.During the investigation, a puncture to the bladder, consistent with contact from a sharp object, was found near the proximal end of the bladder membrane which could allow blood to enter the helium pathway.No other leaks were detected during functional testing.The root cause of the bladder leak is undetermined, but a potential cause of how the catheter came into contact with a sharp object is 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 complaint.There are no new or revised 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: 10861061
• MDR Text Key: 216878845
• Report Number: 3010532612-2020-00365
• 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,Followup
• Report Date: 11/09/2020

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: 12/31/2020
• Device Model Number: IPN000263
• Device Catalogue Number: IAB-S840C
• Device Lot Number: 18F19A0026
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2020
• Initial Date Manufacturer Received: 11/09/2020
• Initial Date FDA Received: 11/18/2020
• Supplement Dates Manufacturer Received: 12/29/2020; 05/24/2021
• Supplement Dates FDA Received: 12/30/2020; 06/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1