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

Catalog Number IAB-05840-LWS

Device Problems Break (1069); Crack (1135); Fluid/Blood Leak (1250)

Patient Problem Injury (2348)

Event Date 03/31/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the intra-aortic balloon (iab) was in use, it was noted by the registered nurse (rn) that the transducer connection to the central lumen was cracked and the male connector broke off in the metal hub of the catheter.The rn stated that the pump alarmed, and blood was found at the central lumen.As a result, another iab was inserted into the patient.The patient was brought to the cath lab where a new iab was, successfully placed in the opposite groin.There was a report of delay in therapy.There was no report of patient death.

Event Description

It was reported that the intra-aortic balloon (iab) was in use, it was noted by the registered nurse (rn) that the transducer connection to the central lumen was cracked and the male connector broke off in the metal hub of the catheter.The rn stated that the pump alarmed, and blood was found at the central lumen.As a result, another iab was inserted into the patient.The patient was brought to the cath lab where a new iab was, successfully placed in the opposite groin.There was a report of delay in therapy.There was no report of patient death.

Manufacturer Narrative

(b)(4).Teleflex did not receive the device for investigation therefore the reported complaint of iab ap tubing leak 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.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 revised risks.This 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: 8540639
• MDR Text Key: 142784606
• Report Number: 3010532612-2019-00106
• 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: 03/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2020
• Device Catalogue Number: IAB-05840-LWS
• Device Lot Number: 18F18K0012
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1