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

Model Number IPN000260

Device Problems Fluid/Blood Leak (1250); Fracture (1260)

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# 3010532612-2020-00093 ((b)(4)) as the reports are related to the same patient.

Event Description

It was reported by the distributor that after insertion of the iab, the staff noted the waveform was strange and noted blood in the iab within 5 mins after the pump was started.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 by the distributor that after insertion of the iab, the staff noted the waveform was strange and noted blood in the iab within 5 mins after the pump was started.There was a report of patient death.Dr.(b)(6) and nurses made the medical judgement that the device did not contribute to patient's death.

Manufacturer Narrative

(b)(4).Teleflex received the device for investigation.The reported complaint of iab blood in the helium pathway is confirmed.Numerous punctures to the bladder, consistent with contact from a sharp object, were found on the bladder membrane which allowed 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 revived risk.This will be monitored for any developing trends.Other remarks: see mdr# 3010532612-2020-00092 ((b)(4)) and mdr# 3010532612-2020-00093 ((b)(4)) 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: 9930527
• MDR Text Key: 186685478
• Report Number: 3010532612-2020-00094
• 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

• Date FDA Received: 04/06/2020
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2020
• Date Manufacturer Received: 05/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1