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

Catalog Number IAB-05840-LWS

Device Problems Occlusion Within Device (1423); Aspiration Issue (2883)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/07/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It has been reported via a hot line call.The registered nurse (rn) from the cardiac intensive care unit (cicu) called for advice on the arterial pressure (ap) waveform source.The central lumen is now clotted and they have no arterial pressure (ap) waveform on the pump.The pump s/n (b)(4) has continued pumping using weissler timing.Patient is in (nsr) normal sinus rhythm, the clinical support specialist explained this timing method to the rn.The patient is currently stable.The rn stated that they have the side port on the sheath.The clinical support specialist (css) asked if the rn had a radial arterial line (a-line) since the patient came from the operating room (or) and the rn replied yes, but it's connected to the monitor and they have no ability to slave it.The css explained to the rn how to connect the radial to the pump and the side port to the monitor so that a waveform would be present there as well.The css and rn discussed this at length.The central lumen is unable to aspirate and has been capped.Per the rn they were using heparinized saline flush and it's possible that the pressure on the pressure bag had gone down.The css asked that the rn call back after she gets the radial connected to the pump.At 2220 the rn called back and reported that the radial is connected to the pump and a waveform is present.The css reviewed the waveform with the rn and the pump is achieving the goals of therapy.

Manufacturer Narrative

(b)(4).Teleflex could not perform a full evaluation on this complaint as no device was returned.A device history record (dhr) review was conducted for the lot number/serial number with no relevant findings.The device passed all manufacturing specifications prior to release.The reported complaint of central lumen occluded is not able to be confirmed.The product was not returned for evaluation, therefore the root cause of the complaint is undetermined.

Event Description

It has been reported via a hot line call.The registered nurse (rn) from the cardiac intensive care unit (cicu) called for advice on the arterial pressure (ap) waveform source.The central lumen is now clotted and they have no arterial pressure (ap) waveform on the pump.The pump s/n (b)(4) has continued pumping using weissler timing.Patient is in (nsr) normal sinus rhythm, the clinical support specialist explained this timing method to the rn.The patient is currently stable.The rn stated that they have the side port on the sheath.The clinical support specialist (css) asked if the rn had a radial arterial line (a-line) since the patient came from the operating room (or) and the rn replied yes, but it's connected to the monitor and they have no ability to slave it.The css explained to the rn how to connect the radial to the pump and the side port to the monitor so that a waveform would be present there as well.The css and rn discussed this at length.The central lumen is unable to aspirate and has been capped.Per the rn they were using heparinized saline flush and it's possible that the pressure on the pressure bag had gone down.The css asked that the rn call back after she gets the radial connected to the pump.At 2220 the rn called back and reported that the radial is connected to the pump and a waveform is present.The css reviewed the waveform with the rn and the pump is achieving the goals of therapy.

• Brand Name: FIBEROPTIX ULTRA 8 IAB: 8FR 40CC
• Type of Device: INTRA- AORTIC BALLOON FIBER OPTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 9 plymouth street; everett MA 02149
• Manufacturer Contact: carmen sherman ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 6223631
• MDR Text Key: 63916796
• Report Number: 1219856-2016-00292
• 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: 12/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2018
• Device Catalogue Number: IAB-05840-LWS
• Device Lot Number: 18F16G0001
• Other Device ID Number: 00801902007247
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/07/2016
• Initial Date FDA Received: 01/04/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/27/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2016
• 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