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 Needle Stick/Puncture (2462)

Event Date 07/29/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the nurse saw flecks of blood in the intra-aortic balloon (iab) driveline associated with a helium loss alarm.As a result, the ruptured iab was removed in the unit and the second iab was placed in the opposing femoral artery.There was no report of patient consequence or death.

Manufacturer Narrative

(b)(4).Teleflex received the device for investigation.The reported complaint of iab blood in helium pathway is confirmed.During the investigation, blood was confirmed within the iabc helium pathway.The iabc was returned with a damaged bladder.The cause of how the blood entered the helium pathway was unable to be determined due to the returned state of the device.The root cause of how the blood entered the helium pathway 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.

Event Description

It was reported that the nurse saw flecks of blood in the intra-aortic balloon (iab) driveline associated with a helium loss alarm.As a result, the ruptured iab was removed in the unit and the second iab was placed in the opposing femoral artery.There was no report of patient consequence 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: 10439359
• MDR Text Key: 203990048
• Report Number: 3010532612-2020-00227
• 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: 08/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2022
• Device Model Number: IPN000254
• Device Catalogue Number: IAB-05840-LWS
• Device Lot Number: 18F20E0023
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2020
• Date Manufacturer Received: 09/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 67 YR