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

Catalog Number IAB-05840-LWS

Device Problems Difficult to Flush (1251); Occlusion Within Device (1423); Use of Device Problem (1670)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/11/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported by the register nurse that after drawing blood from the catheter, the waveform would not come back.The arterial pressure waveforms disappeared.The catheter is now clotted off.They tried to flush the catheter and zero it without success.The clinical support specialist (css) discussed with the rn that the central lumen should not be used to draw blood.The css asked the rn to have an alternate art line placed and they can use that to monitor.There was no reported patient death or complications.

Manufacturer Narrative

(b)(4).Teleflex did not receive the device for investigation therefore the reported complaint of central lumen occluded is not able to be confirmed.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.The reported complaint will be monitored for any developing trends.If the product is returned at a later date, a full investigation of the sample will be completed.No further action required.Other remarks: related complaint (b)(4).

Event Description

It was reported by the rn that after drawing blood from the catheter, the waveform would not come back.The arterial pressure waveforms disappeared.The catheter is now clotted off.They tried to flush the catheter and zero it without success.The clinical support specialist (css) discussed with the rn that the central lumen should not be used to draw blood.The css asked the rn to have an alternate art line placed and they can use that to monitor.There was no reported patient death or complications.

• 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.; 9 plymouth street; everett MA 02149
• Manufacturer Contact: carmen sherman ; 16 elizabeth drive; chelmsford, MA 01824 ; 9782505100
• MDR Report Key: 6922309
• MDR Text Key: 88432451
• Report Number: 1219856-2017-00225
• 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: 09/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2018
• Device Catalogue Number: IAB-05840-LWS
• Device Lot Number: 18F16L0001
• Other Device ID Number: 00801902007247
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/09/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2016
• 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