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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 Unable to Obtain Readings (1516); No Pressure (2994)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/13/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that while in the (ccl) cardiac cath lab the (iab) intra-aortic balloon catheter was prepped and the (fos) fiber optic signal would not zero prior to insertion on initial attempt, and then retried and zeroed. The iab was inserted via a sheath into the patient's left femoral artery. The patient was moved to the (cicu) cardiac intensive care unit and at that time the fos was lost. The rn tried to map calibrate the central lumen, however this was unsuccessful. The central lumen had a clot and as a result it was affecting the waveform. They did have a pressure bag in use. Due to this issue, they used the (ap) arterial pressure signal from a femoral source. There was a 2 minute delay in iabp therapy. There were no reports of patient death, injury, or complications.
 
Manufacturer Narrative
(b)(4). No product was returned for evaluation. 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. Conclusion: the reported complaint of central lumen occluded is not able to be confirmed. No product was returned for evaluation. The root cause of the complaint is undetermined.
 
Event Description
It was reported that while in the (ccl) cardiac cath lab the (iab) intra-aortic balloon catheter was prepped and the (fos) fiber optic signal would not zero prior to insertion on initial attempt, and then retried and zeroed. The iab was inserted via a sheath into the patient's left femoral artery. The patient was moved to the (cicu) cardiac intensive care unit and at that time the fos was lost. The rn tried to map calibrate the central lumen, however this was unsuccessful. The central lumen had a clot and as a result it was affecting the waveform. They did have a pressure bag in use. Due to this issue, they used the (ap) arterial pressure signal from a femoral source. There was a 2 minute delay in iabp therapy. There were no reports of patient death, injury, or complications.
 
Manufacturer Narrative
(b)(4). The sample was returned in a clear biohazard bag within the supplied return kit. The distal end of the teflon sheath was approximately 38. 2cm from the iab distal tip. The teflon sheath was connected to the iab hemostasis cuff which was connected to the cathgard. A pressure tubing assembly was connected to the sheath sidearm. Dried blood was noted on the exterior of the sheath, outer lumen, one-way valve, bifurcate, bladder and fos cabling. The one-way valve was tethered to the short driveline tubing. The bladder was fully unwrapped. The fos connector and cal key were examined. The fos connector was properly seated in the housing and both retaining tabs were intact. The center post of the fos was centered. The blue slide housing was examined and no abnormalities were noted. The cal key was intact. The one-way valve was tested and passed. A vacuum was pulled on the one-way valve and it held for at least 1 minute and then 30 seconds five separate times. The cal key and fos were connected to the iabp. The cal key was recognized. The pump status displayed "ll" low light and "pl" pressure limit, indicating a possible broken fiber. The fiber was found broken approximately 1. 1cm from iab distal tip. A lab inventory 0. 025in guidewire was back loaded through iab distal tip. No resistance was noted; the guidewire was able to advance through the central lumen. No blood or debris was noted. The guidewire was front loaded through the iab luer. No resistance was noted; the guidewire was able to advance through the central lumen. No blood or debris was noted. The iab was submerged in water and leak tested. No holes or leaks were detected. Full inflation was achieved. The unit passed leak test. The catheter was aspirated and flushed using a 60cc lab-inventory syringe. No abnormalities or debris were noted. 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. Conclusion: the reported complaint of central lumen occluded is not confirmed. The guidewire and aspiration/flushing tests were successful with no issues. No bends were noted. The root cause of the reported complaint is undetermined.
 
Event Description
It was reported that while in the (ccl) cardiac cath lab the (iab) intra-aortic balloon catheter was prepped and the (fos) fiber optic signal would not zero prior to insertion on initial attempt, and then retried and zeroed. The iab was inserted via a sheath into the patient's left femoral artery. The patient was moved to the (cicu) cardiac intensive care unit and at that time the fos was lost. The rn tried to map calibrate the central lumen, however this was unsuccessful. The central lumen had a clot and as a result it was affecting the waveform. They did have a pressure bag in use. Due to this issue, they used the (ap) arterial pressure signal from a femoral source. There was a 2 minute delay in iabp therapy. There were no reports of patient death, injury, or complications.
 
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Brand NameFIBEROPTIX ULTRA 8 IAB: 8FR 40CC
Type of DeviceINTRA- 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
anne rosenberger
2400 bernville road
reading, PA 19605
6104783117
MDR Report Key5782448
MDR Text Key49190479
Report Number1219856-2016-00167
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K021462
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 06/13/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/11/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/30/2017
Device Catalogue NumberIAB-05840-LWS
Device Lot Number18S15D0034
Other Device ID Number00801902007247
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/22/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/21/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/25/2016
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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