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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 Problem Inflation Problem (1310)
Patient Problems Cardiogenic Shock (2262); No Known Impact Or Consequence To Patient (2692)
Event Date 08/20/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4). See mdr 1219856-2016-00202 for the second report involving the same patient.
 
Event Description
It was reported via a hotline call. The perfusionist was calling about balloon insertions over the weekend, he stated that they had issues with two fiberoptix iabs over the weekend. They had an emergent case in the cath lab with a patient 5'6" in height. They inserted a 40 cc fiberoptix, that was zeroed (they heard the click, audible tone, and icon color change), the insertion was without difficulty. They got an arterial pressure waveform, but when they started the pump pumping, they got an immediate "high pressure" alarm. They checked the position and the perfusionist even tried manually inflating and deflating the balloon. Per the perfusionist they still got the "high pressure" alarm. The perfusionist next decreased the volume to 40%. They still had alarms. The physician at that point decided to remove this balloon and insert a second balloon. The clinical support specialist explained that the iab may have had a severe kink and that was giving them the "high pressure" alarms. Since the md was able to manual inflate and deflate the balloon to make sure it was unwrapped. The balloon was connected to pump sn: (b)(4).
 
Manufacturer Narrative
(b)(4). See mdr 1219856-2016-00202. The sample was returned with the supplied return kit and was in a sealed bio-hazard bag. An ap pressure tubing and dilator were returned with the sample. Upon return, a 40cc inflation driveline tubing was connected to the short driveline tubing. Dried blood was noted on the exterior of the driveline tubing but not inside. The teflon sheath was approximately 49 cm from the iab distal tip. The sheath was connected to the iab hemostasis cuff which was connected to the cathgard. The one-way valve was tethered to the short driveline tubing. The bladder was fully unwrapped. Dried blood was noted on the exterior of the bifurcate, one-way valve, sheath, outer lumen and bladder. 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. See other remarks section. Other remarks: 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. 4cm from iab distal tip. The full length of the fiber was confirmed present with no other notable breaks. The iab was submerged in water and leak tested. A leak was immediately noticeable from the bifurcate around the fos cable. Upon microscopic inspection, the leak occurred around the fos adhesive bond to the bifurcate. The root cause of how the leak occurred is undetermined. Engineering has been notified of the issue. This issue will be monitored for any developing trends. The catheter was aspirated and flushed using a 60cc lab-inventory syringe. No abnormalities or debris were noted. A lab inventory 0. 025in guidewire was back loaded through the iab distal tip. Resistance was noted at approximately 73. 5cm from the iab distal tip. 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. Resistance was noted at approximately 9. 3cm from the iab luer. The guidewire was able to advance through the central lumen. No blood or debris was 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 leak (suspected) is confirmed. An external leak is confirmed from the iab bifurcate around the fos adhesive. The root cause of how the leak occurred is undetermined. Engineering has been notified of the issue. This issue will be monitored for any developing trends.
 
Event Description
It was reported via a hotline call. The perfusionist was calling about balloon insertions over the weekend, he stated that they had issues with two fiberoptix iabs over the weekend. They had an emergent case in the cath lab with a patient (b)(6) in height. They inserted a 40 cc fiberoptix, that was zeroed (they heard the click, audible tone, and icon color change), the insertion was without difficulty. They got an arterial pressure waveform, but when they started the pump pumping, they got an immediate "high pressure" alarm. They checked the position and the perfusionist even tried manually inflating and deflating the balloon. Per the perfusionist they still got the "high pressure" alarm. The perfusionist next decreased the volume to 40%. They still had alarms. The physician at that point decided to remove this balloon and insert a second balloon. The clinical support specialist explained that the iab may have had a severe kink and that was giving them the "high pressure" alarms. Since the md was able to manual inflate and deflate the balloon to make sure it was unwrapped. The balloon was connected to pump sn: (b)(4).
 
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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 Key5964307
MDR Text Key55210202
Report Number1219856-2016-00201
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,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 08/22/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/20/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/30/2018
Device Catalogue NumberIAB-05840-LWS
Device Lot Number18F16F0042
Other Device ID Number00801902007247
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/26/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/12/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/24/2016
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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