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 07/28/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that blood was noted inside the intra-aortic balloon (iab) helium driveline.The staff has had no alarms and the blood is noted in the tubing outside the intra-aortic balloon pump (iabp) about 12-16 inches, but no other location, and not close to the patient.The staff confirmed there was zero alarms all day and none were reported from previous shifts.The staff check the condensation trap and there is (clear) water present.No blood tinge noted.As a result, the iab and iabp was swapped out.There was no report of patient complications, serious injury or death.

Event Description

It was reported that blood was noted inside the intra-aortic balloon (iab) helium driveline.The staff has had no alarms and the blood is noted in the tubing outside the intra-aortic balloon pump (iabp) about 12-16 inches, but no other location, and not close to the patient.The staff confirmed there was zero alarms all day and none were reported from previous shifts.The staff check the condensation trap and there is (clear) water present.No blood tinge noted.As a result, the iab and iabp was swapped out.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 iab blood in helium pathway is confirmed.Numerous punctures to the bladder, consistent with contact from a sharp object, were found on the bladder membrane which caused 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 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.

• 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: 10422668
• MDR Text Key: 203455503
• Report Number: 3010532612-2020-00220
• 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: 07/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2020
• Device Model Number: IPN000254
• Device Catalogue Number: IAB-05840-LWS
• Device Lot Number: 18F18K0013
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2020
• Date Manufacturer Received: 09/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1