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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 Material Rupture (1546)
Patient Problem Angina (1710)
Event Date 05/19/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that while in the coronary care unit the iab was prepped for insertion and inserted via a sheath into the patient's right femoral artery. After 18 hours of iabp therapy the pump alarmed with a "high pressure" alarm and blood was noted in the helium tubing. The tubing was clamped and the iab was removed successfully. The md stated that the patient did not require a second iab because he was much better and stable. There was a reported interruption in iabp therapy however no harm to the patient was reported. The patient outcome is listed as okay.
 
Manufacturer Narrative
Qn#(b)(4). Returned for evaluation was a 40cc 8. 0fr fos iab. The sample was returned with the supplied return kit. Upon return, a 40cc inflation driveline tubing, with forceps clamping the tubing, was connected to the short driveline tubing. Blood was noted on the interior of the 40cc inflation driveline tubing. A pressure line was connected to the iab luer. Fluid was noted on the interior of the ap pressure tubing. The distal end of the teflon sheath was approximately 47. 3cm from the iab distal tip. The teflon sheath was connected to the iab hemostasis cuff which was connected to the cathgard blood was observed on the exterior of the sheath, bifurcate, cathgard and on the interior of the bladder, outer lumen and short driveline tubing. Dried blood was noted on the exterior of the one-way valve. 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 bladder thickness was measured at six points with measurements within specification. See other remarks section. Other remarks: the one-way valve was tested and failed. A vacuum was pulled on the iab and it immediately lost pressure. This was repeated five separate times with similar results. The one-way valve was properly cleaned and tested again; the one-way valve passed. A vacuum was pulled on the one-way valve and it held for at least 1 minute and then 30 seconds five separate. 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. 5cm 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 bladder membrane. Under microscopic inspection, a puncture consistent with damage from the broken fiber was noted approximately 1. 7cm from the distal tip of the iab. 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. Some blood was noted on the guidewire upon pullout. The guidewire was front loaded through the iab luer. No resistance was noted; the guidewire was able to advance through the central lumen. Some blood was noted on the guidewire upon pullout. 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 one relevant finding. The device was manufa ctured prior to the field correction action recall for sheath hub separation (capa reference no. (b)(4)). The product was not found with this issue. Conclusion: the reported complaint of blood in helium pathway is confirmed. A puncture consistent with contact from the broken fiber was found near the distal tip of the iab which likely allowed blood to enter the helium pathway. The root cause of the broken fiber is undetermined.
 
Event Description
It was reported that while in the coronary care unit the iab was prepped for insertion and inserted via a sheath into the patient's right femoral artery. After 18 hours of iabp therapy the pump alarmed with a "high pressure" alarm and blood was noted in the helium tubing. The tubing was clamped and the iab was removed successfully. The md stated that the patient did not require a second iab because he was much better and stable. There was a reported interruption in iabp therapy however no harm to the patient was reported. The patient outcome is listed as okay.
 
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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 Key5747701
MDR Text Key48098896
Report Number1219856-2016-00133
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
Reporter Occupation Other Health Care Professional
Remedial Action Recall
Type of Report Initial,Followup
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/24/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/30/2017
Device Catalogue NumberIAB-05840-LWS
Device Lot Number18F15J0028
Other Device ID Number00801902007247
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/07/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/27/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/14/2015
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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