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

Catalog Number IAB-05840-LWS

Device Problems Device Alarm System (1012); Fluid/Blood Leak (1250); Material Rupture (1546)

Patient Problems Vessel Or Plaque, Device Embedded In (1204); Injury (2348)

Event Date 11/18/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported by the medical doctor that the intra-aortic balloon (iab) ruptured.The intra-aortic balloon pump (iabp) alarmed for possible helium loss.The patient was taken to the operating room to have the iab surgically removed due to a clot formation.A second iab was inserted in the patient.There was no report of patient death.

Event Description

It was reported by the medical doctor that the intra-aortic balloon (iab) ruptured.The intra-aortic balloon pump (iabp) alarmed for possible helium loss.The patient was taken to the operating room to have the iab surgically removed due to a clot formation.A second iab was inserted in the patient.There was no report of patient death.

Manufacturer Narrative

(b)(4).For related event see mdr #3010532612-2018-00406 and tc #1900064646.Other device codes: 1528.Teleflex did not receive the device for investigation therefore the reported complaint of blood in helium pathway is not able to be confirmed.The root cause of the complaint is undetermined.If the product is returned at a later date, a full investigation of the sample will be completed.The specific serial number/lot number was not reported, but a device history record (dhr) review was conducted for the lot numbers shipped to this account with no relevant findings.All devices passed manufacturing specifications prior to release.Teleflex assessed the risk for the reported complaint.There are no new or revised risks.The reported complaint will be monitored for any developing trends.No further action required at this time.

• 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: 8159517
• MDR Text Key: 130177225
• Report Number: 3010532612-2018-00376
• 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: 11/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: IAB-05840-LWS
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/20/2018
• Initial Date FDA Received: 12/13/2018
• Supplement Dates Manufacturer Received: 01/17/2019
• Supplement Dates FDA Received: 01/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1