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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 Fluid Leak (1250); Material Rupture (1546)
Patient Problem Atherosclerosis (1728)
Event Date 08/27/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported via a hotline call to the clinical support specialist (css) from the perfusionist regarding a ruptured intra-aortic balloon catheter (iab). They have a patient that they is in the or preparing for coronary artery bypass graft (cabg) surgery. It was reported to them that the patient got out of bed in the night. As they got the patient over onto the surgery table, they noted blood in the tubing. They will be taking the balloon out, but the surgeon wanted to know what size guidewire to use to exchange the balloon. The surgeon is planning to take the balloon out and place a sheath in case they need to place another balloon during surgery. The css told the perfusionist to tell the surgeon that the central lumen is a 0. 27 and requires a 0. 25 or smaller wire. The css explained that the wire in the balloon kit is 175 cm long and long enough to exchange the balloon out. They could also use an exchange wire. The css also told the perfusionist to tell the surgeon that he may need to place a larger sheath since the whole will be larger than the 8 french when they remove the balloon and sheath. The surgeon understood. The iab had been placed yesterday in the cath lab. The iab pump was sent to biomed.
 
Manufacturer Narrative
(b)(4). The serial number recorded on the complaint report is ls40263. The bifurcate was not returned with the device therefore the serial number of the device cannot be determined. The iab bifurcate, luer, short driveline tubing, one-way valve and fos cabling/connector were not returned. The returned device was approximately 73. 6cm in length and included the iab central lumen, outer lumen, fos fiber, bladder, sheath and distal tip. A. 025in guidewire and cathgard were also noted with the returned device. The teflon sheath was approximately 32cm from the iab distal tip. The cathgard was found loosely on the guidewire. The guidewire was found inserted within the outer lumen, not the central lumen, with approximately 127cm of the guidewire exposed. The guidewire was found curled up within the proximal end of the bladder. The central lumen was confirmed broken at approx. 70. 7cm from the iab distal tip. The fos fiber was found broken at 72. 6cm. The appearance at the area of the broken outer lumen was consistent with cut from a sharp. Dried blood was noted on the exterior surfaces of the iab and on the interior of the outer lumen and bladder. The bladder was fully unwrapped. The bladder was visually inspected with no damage or abnormalities noted. Functional testing of the device was unable to be performed due to the returned state of the device. The guidewire was unable to be removed from the catheter due to the way it was inserted within the outer lumen/bladder membrane. 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 blood in helium pathway is confirmed based on visual inspection. The returned iab was too damaged to analyze. The damage to the iab is consistent with removal difficulty. The root cause of how the blood entered the helium pathway is not able to be determined.
 
Event Description
It was reported via a hotline call to the clinical support specialist (css) from the perfusionist regarding a ruptured intra-aortic balloon catheter (iab). They have a patient that is in the o. R. Preparing for coronary artery bypass graft (cabg) surgery. It was reported to them that the patient got out of bed in the night. As they got the patient over onto the surgery table, they noted blood in the tubing. They will be taking the balloon out, but the surgeon wanted to know what size guidewire to use to exchange the balloon. The surgeon is planning to take the balloon out and place a sheath in case they need to place another balloon during surgery. The css told the perfusionist to tell the surgeon that the central lumen is a 0. 27 and requires a 0. 25 or smaller wire. The css explained that the wire in the balloon kit is 175 cm long and long enough to exchange the balloon out. They could also use an exchange wire. The css also told the perfusionist to tell the surgeon that he may need to place a larger sheath since the hole will be larger than the 8 french when they remove the balloon and sheath. The surgeon understood. The iab had been placed yesterday in the cath lab. The iab pump was sent to biomed.
 
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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 Key5968121
MDR Text Key55323643
Report Number1219856-2016-00208
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 health professional,user faci
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 08/27/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/21/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/31/2016
Device Catalogue NumberIAB-05840-LWS
Device Lot Number18R14M0026
Other Device ID Number00801902007247
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/12/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/19/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/22/2014
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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