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

Catalog Number IAB-05840-LWS

Device Problem Occlusion Within Device (1423)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/05/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Other remarks: for related complaint see mdr #1219856-2018-00023 and (b)(4).

Event Description

It was reported by the rn that she has a patient that transferred from an outside hospital with an intra-aortic balloon pump (iabp).The rn reported that the systolic and diastolic pressures were the same.They were using a fiber-optic catheter and the light bulb was green.The clinical support specialist (css) had the rn switch to transducer and level and zero the transducer.The css talked her through the calibration procedure, and the hemodynamics did not change.A cardiology fellow came to the bedside and attempted to draw back on the catheter and stated he could not get anything back.The css told him that there must be a clot on the end of the catheter and the fiber optic sensor (fos) may be covered by the clot as well.The css told the md that they could place an arterial line to use for monitoring the timing and patient.The cardiology fellow did not want to place another line and was going to call the attending md.The css explained that the clot could have started to form at insertion.The md stated the patient was stable.The iab was taken out the following day.There was no reported patient death, serious injury or patient complications.No medical intervention was required and no delay or interruption in therapy.

Manufacturer Narrative

(b)(4).Teleflex received the device for investigation.The reported complaint of central lumen occluded is not able to be confirmed.The cause of the complaint was unable to be determined due to the returned state of the device.Due to the damage, the device was unable to be functionally tested.The root cause of the complaint 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.This will be monitored for any developing trends.No further action required at this time.Other remarks: for related complaint see mdr #1219856-2018-00023 and (b)(4).

Event Description

It was reported by the rn that she has a patient that transferred from an outside hospital with an intra-aortic balloon pump (iabp).The rn reported that the systolic and diastolic pressures were the same.They were using a fiber-optic catheter and the light bulb was green.The clinical support specialist (css) had the rn switch to transducer and level and zero the transducer.The css talked her through the calibration procedure, and the hemodynamics did not change.A cardiology fellow came to the bedside and attempted to draw back on the catheter and stated he could not get anything back.The css told him that there must be a clot on the end of the catheter and the fiber optic sensor (fos) may be covered by the clot as well.The css told the md that they could place an arterial line to use for monitoring the timing and patient.The cardiology fellow did not want to place another line and was going to call the attending md.The css explained that the clot could have started to form at insertion.The md stated the patient was stable.The iab was taken out the following day.There was no reported patient death, serious injury or patient complications.No medical intervention was required and no delay or interruption in therapy.

• Brand Name: FIBEROPTIX ULTRA 8 IAB: 8FR 40CC
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 16 elizabeth drive; chelmsford MA 01824
• Manufacturer Contact: carmen sherman ; 16 elizabeth drive; chelmsford, MA 01824 ; 9782505100
• MDR Report Key: 7228887
• MDR Text Key: 98677148
• Report Number: 1219856-2018-00027
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K021462
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 01/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2019
• Device Catalogue Number: IAB-05840-LWS
• Device Lot Number: 18F17F0002
• Other Device ID Number: 00801902007247
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/01/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/02/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1