MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ULTRAFLEX IAB: 7.5FR 40CC; SYSTEM, BALLOON, INTRA-AORTIC

Model Number IPN000260

Device Problem Difficult to Insert (1316)

Patient Problems Calcium Deposits/Calcification (1758); Death (1802)

Event Date 03/16/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Other remarks: see mdr# 3010532612-2020-00092 ((b)(4)) and mdr# 3010532612-2020-00094 ((b)(4)) as the reports are related to the same patient.

Event Description

It was reported that a second intra-aortic balloon (iab) was used on the patient and difficulties were encountered when inserting.The original sheath provided in the insertion tray was difficult to insert.The femoral access site the staff stated was seriously calcified.As a result, a new sheath was used.There was a report of patient death.(b)(6) and nurses made the medical judgement that the device did not contribute to patient's death.

Event Description

It was reported that a second intra-aortic balloon (iab) was used on the patient and difficulties were encountered when inserting.The original sheath provided in the insertion tray was difficult to insert.The femoral access site the staff stated was seriously calcified.As a result, a new sheath was used.There was a report of patient death.Dr.Chan and nurses made the medical judgement that the device did not contribute to patient's death.

Manufacturer Narrative

(b)(4).No iab parts was returned to teleflex chelmsford for investigation.The reported complaint of sheath difficult to advance in 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.Other remarks: see mdr# 3010532612-2020-00092 (tc1900076197) and mdr# 3010532612-2020-00094 (tc1900076199) as the reports are related to the same patient.

• Brand Name: ULTRAFLEX IAB: 7.5FR 40CC
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 9930509
• MDR Text Key: 186685876
• Report Number: 3010532612-2020-00093
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 00801902026804
• UDI-Public: 00801902026804
• Combination Product (y/n): N
• PMA/PMN Number: K000729
• 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: 03/16/2020

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: 01/31/2021
• Device Model Number: IPN000260
• Device Catalogue Number: IAB-06840-U
• Device Lot Number: 18F19B0014
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 03/16/2020
• Initial Date FDA Received: 04/06/2020
• Supplement Dates Manufacturer Received: 05/01/2020
• Supplement Dates FDA Received: 05/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1