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U.S. Department of Health and Human Services

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

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ARROW INTERNATIONAL INC. FIBEROPTIX ULTRA 8 IAB: 8FR 40CC INTRA- AORTIC BALLOON FIBER OPTIC Back to Search Results
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.
 
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Brand NameFIBEROPTIX ULTRA 8 IAB: 8FR 40CC
Type of DeviceINTRA- 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 Key6516906
MDR Text Key73573248
Report Number1219856-2017-00073
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K021462
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/30/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/24/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/28/2019
Device Catalogue NumberIAB-05840-LWS
Device Lot Number18F17B0034
Other Device ID Number00801902007247
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/05/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/18/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/16/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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