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 Partial Blockage (1065); Unable to Obtain Readings (1516); Failure to Calibrate (2440)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/30/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported via a hot line call.The registered nurse (rn) from the cardiac intensive care unit (cicu) is calling the clinical support specialist (css) with a patient that came to them early this morning with the intra-aortic balloon (iab) in place from the cath lab.The pump has been operating as expected, however the arterial pressure (ap) waveform will dampen at times.Now it is becoming increasingly more difficult to keep a good waveform from the central lumen.The rn stated that she has flushed several times, and also drawn blood back followed by a thorough flush.She was also calling to troubleshoot why the fiber optic sensor (fos) is not working.The fos lightbulb is black with a blue ground (fiber-optix not connected).Fos status codes are low light (ll), outside of pressure range (pl), ratio metric error (re), and excessive offset (eo).The css first verified that there have been no delays in therapy, and the pump is currently pumping.They are hoping to get a better waveform.The css first had them check the fos connector, and the tip is not recessed as reported by the rn.The css had her reconnect the fos and cal.Key a couple of times with no change.The css and rn discussed that the fos is not working on this iab.They then discussed how the pump is already using the transducer from the central lumen.The rn is concerned about the decline of the quality of the waveform from that source.The css and rn discussed that should they need to use a different ap source that a radial arterial-line would be the next best source for the ap.The rn stated that she will try to get a radial arterial-line placed.They discussed saving the iab being saved after removal to be sent back.She stated that she will pass that on, but is not hopeful that it will actually happen.Patient outcome: stable on the pump.Length of time in use prior to event: 8 hours.Additional information received from the rn stated that the iab is still in the patient.The patient is being weaned off the iab.The iab was not removed or replaced.She will save the iab.

Manufacturer Narrative

(b)(4).Teleflex received the device for evaluation.The reported complaint of central lumen occluded is confirmed.The aspiration/flushing test was successful; however a kink was noted approximately 51.5cm from the iab distal tip and is the probable cause of the reported complaint.The root cause of the kink 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.Teleflex assessed the risk for the reported complaint.There are no new or revised risks.This issue will be monitored for any developing trends.

Event Description

It was reported via a hot line call.The registered nurse (rn) from the cardiac intensive care unit (cicu) is calling the clinical support specialist (css) with a patient that came to them early this morning with the intra-aortic balloon (iab) in place from the cath lab.The pump has been operating as expected, however the arterial pressure (ap) waveform will dampen at times.Now it is becoming increasingly more difficult to keep a good waveform from the central lumen.The rn stated that she has flushed several times, and also drawn blood back followed by a thorough flush.She was also calling to troubleshoot why the fiber optic sensor (fos) is not working.The fos lightbulb is black with a blue ground (fiber-optix not connected).Fos status codes are low light (ll), outside of pressure range (pl), ratio metric error (re), and excessive offset (eo).The css first verified that there have been no delays in therapy, and the pump is currently pumping.They are hoping to get a better waveform.The css first had them check the fos connector, and the tip is not recessed as reported by the rn.The css had her reconnect the fos and cal.Key a couple of times with no change.The css and rn discussed that the fos is not working on this iab.They then discussed how the pump is already using the transducer from the central lumen.The rn is concerned about the decline of the quality of the waveform from that source.The css and rn discussed that should they need to use a different ap source that a radial arterial-line would be the next best source for the ap.The rn stated that she will try to get a radial arterial-line placed.They discussed saving the iab being saved after removal to be sent back.She stated that she will pass that on, but is not hopeful that it will actually happen.Patient outcome: stable on the pump.Length of time in use prior to event: 8 hours additional information received from the rn stated that the iab is still in the patient.The patient is being weaned off the iab.The iab was not removed or replaced.She will save the iab.

• Brand Name: FIBEROPTIX ULTRA 8 IAB: 8FR 40CC
• Type of Device: INTRA- AORTIC BALLOON FIBER OPTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; chelmsford MA
• 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: 6516906
• MDR Text Key: 73573248
• Report Number: 1219856-2017-00073
• 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: 03/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2019
• Device Catalogue Number: IAB-05840-LWS
• Device Lot Number: 18F17B0034
• Other Device ID Number: 00801902007247
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/16/2017
• 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