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

Model Number IPN000263

Device Problems Material Puncture/Hole (1504); Gas/Air Leak (2946)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/17/2020

Event Type  malfunction  

Manufacturer Narrative

Qn: (b)(4).

Event Description

It was reported that after passing the intra-aortic balloon (iab) the staff received a helium gas alert.The intra-aortic balloon pump (iabp) was inspected and presented no problems.As a result, the staff made it necessary to carry out another iab, using the same insertion site.There was no report of patient complications, serious injury or death.

Event Description

It was reported that after passing the intra-aortic balloon (iab) the staff received a helium gas alert.The intra-aortic balloon pump (iabp) was inspected and presented no problems.As a result, the staff made it necessary to carry out another iab, using the same insertion site.There was no report of patient complications, serious injury or death.

Manufacturer Narrative

(b)(4).No parts were returned to teleflex chelmsford for investigation.The reported complaint of iab helium loss alarm is not able to be confirmed.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.

• Brand Name: REDIGUARD IAB: 8FR 40CC
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 10705594
• MDR Text Key: 212113394
• Report Number: 3010532612-2020-00316
• 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: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 10/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2021
• Device Model Number: IPN000263
• Device Catalogue Number: IAB-S840C
• Device Lot Number: 18F19K0001
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1