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

Model Number IPN000254

Device Problems Fluid/Blood Leak (1250); Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/01/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the staff had a helium loss 2 alarm and blood was observed in the gas tubing of the intra-aortic balloon (iab).The staff stated that they restarted the intra-aortic balloon pump (iabp), and more blood appeared immediately in the gas tubing and immediately stopped the iabp and called the hotline.The clinical support specialist (css) verified that the gas tubing has small specks of blood present at the end proximal to the patient and that there does not appear to be blood near the iabp end of the tubing.The css explained that the iab has failed and they need to remove as soon as possible.As a result, the iab was successfully removed.The iab was not replaced as the patient was stable without therapy.There was no report of patient complications serious injury, or death.

Manufacturer Narrative

(b)(4).Teleflex received the device for investigation.The reported complaint of blood in helium pathway is confirmed.The iab bladder had a full thickness abrasion, which caused blood to enter the helium pathway.The appearance of the abraded area is consistent with repeated contact with calcified plaque on the aortic wall.Additionally, an external helium leak from the outer lumen was noted with damage consistent from a sharp object or tooling.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 staff had a helium loss 2 alarm and blood was observed in the gas tubing of the intra-aortic balloon (iab).The staff stated that they restarted the intra-aortic balloon pump (iabp), and more blood appeared immediately in the gas tubing and immediately stopped the iabp and called the hotline.The clinical support specialist (css) verified that the gas tubing has small specks of blood present at the end proximal to the patient and that there does not appear to be blood near the iabp end of the tubing.The css explained that the iab has failed and they need to remove as soon as possible.As a result, the iab was successfully removed.The iab was not replaced as the patient was stable without therapy.There was no report of patient complications serious injury, or death.

• Brand Name: FIBEROPTIX ULTRA 8 IAB: 8FR 40CC
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 9985602
• MDR Text Key: 188517668
• Report Number: 3010532612-2020-00108
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 00801902007247
• UDI-Public: 00801902007247
• Combination Product (y/n): N
• PMA/PMN Number: K021462
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 04/01/2020

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: 09/30/2021
• Device Model Number: IPN000254
• Device Catalogue Number: IAB-05840-LWS
• Device Lot Number: 18F19K0026
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2020
• Initial Date Manufacturer Received: 04/01/2020
• Initial Date FDA Received: 04/22/2020
• Supplement Dates Manufacturer Received: 05/28/2020
• Supplement Dates FDA Received: 05/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1