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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 Problem No Consequences Or Impact To Patient (2199)
Event Date 09/29/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4). The sample was discarded.
 
Event Description
It was reported via a hot line call. The (rn) registered nurse from the patient safety department is calling regarding an insertion from yesterday. The rn stated she has an (iab) intra-aortic balloon catheter for return that was inserted "but would not inflate. " they inserted another iab on a different pump and the patient is now supported well without issue. There was a minimal delay in therapy. The rn was not present at the time of insertion and could provide limited information. The rn is unsure if any alarms occurred or what they may have been. The rn stated that they had gone through 2 tanks of helium and it continued to leak so they changed the pump. But the catheter would still "not inflate" so they exchanged the catheter. There was no blood noted in the catheter. The rn is unaware if the same insertion site or different one was used. No reported difficulty with insertion or removal. The clinical support specialist explained to the rn that based on the limited information provided it sounds as if they had some type of alarm and attempted to change the tank to solve the problem and in doing so lost the o-ring for the tank. The css explained that the tank was not likely the cause of the issue, but this created an additional problem. The css explained that without knowledge of alarms and if the iab was unwrapping under fluoroscopy it is difficult to determine what issue they were having with the iab. The rn stated that she is going to try to have someone that was there for the insertion call the css back to provide additional information. The css stressed that she relay the message that they should call the hotline during the issue so that we can assist them and determine quickly what the problem was. It is possible the iab would not have required removal, but without information it is impossible to determine. The rn agreed and said that the css had returned her call in less than 2 minutes and she will stress this for future issues. The rn stated again that the patient is fine with no complications and supported well on the second pump. The rn does not have the serial number of the first or second pump. The css attempted to call the rn back later in the day and left a message.
 
Manufacturer Narrative
(b)(4). The sample was returned with the supplied return kit and was in a clear plastic bag. Included with the sample was a 40cc inflation driveline tubing, a 60ml luer lock syringe and a 60ml syringe. Upon return, the short driveline tubing was cut off at the iab bifurcate. The one-way valve was not returned. The hemostasis cuff was connected to the cathgard. Dried blood was noted on the iab luer. No blood was noted within the interior of the iab. 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. The one-way valve was not returned with the sample; therefore it could not be tested. 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. 3cm from iab distal tip. The full length of the fiber was confirmed present with no other notable breaks. See other remarks section. Other remarks: 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. 4cm from the distal tip of the iab. An attempt to aspirate and flush the catheter using a 60cc lab-inventory syringe was unable to be successfully completed. A lab inventory 0. 025in guidewire was back loaded through the iab distal tip. The guidewire could not advance at approximately 4. 3cm. No blood or debris was noted. The guidewire was front loaded through the iab luer. The guidewire could not advance at approximately 17. 2cm from the iab luer. Dried blood exited with the guidewire. Ifu states: "using current hospital protocol, connect pressure tubing extension to a prepared standard arterial pressure monitoring assembly which delivers 3 cc of pressurized flush per hour. " this action is to maintain the patency of the arterial line. 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 balloon "would not inflate" is confirmed. A puncture to the bladder, consistent with contact from the broken fiber, was found near the distal tip of the iab. This was likely the cause of the reported complaint. The root cause of the broken fiber is undetermined.
 
Event Description
It was reported via a hot line call. The (rn) registered nurse from the patient safety department is calling regarding an insertion from yesterday. The rn stated she has an (iab) intra-aortic balloon catheter for return that was inserted "but would not inflate. " they inserted another iab on a different pump and the patient is now supported well without issue. There was a minimal delay in therapy. The rn was not present at the time of insertion and could provide limited information. The rn is unsure if any alarms occurred or what they may have been. The rn stated that they had gone through 2 tanks of helium and it continued to leak so they changed the pump. But the catheter would still "not inflate" so they exchanged the catheter. There was no blood noted in the catheter. The rn is unaware if the same insertion site or different one was used. No reported difficulty with insertion or removal. The clinical support specialist explained to the rn that based on the limited information provided it sounds as if they had some type of alarm and attempted to change the tank to solve the problem and in doing so lost the o-ring for the tank. The css explained that the tank was not likely the cause of the issue, but this created an additional problem. The css explained that without knowledge of alarms and if the iab was unwrapping under fluoroscopy it is difficult to determine what issue they were having with the iab. The rn stated that she is going to try to have someone that was there for the insertion call the css back to provide additional information. The css stressed that she relay the message that they should call the hotline during the issue so that we can assist them and determine quickly what the problem was. It is possible the iab would not have required removal, but without information it is impossible to determine. The rn agreed and said that the css had returned her call in less than 2 minutes and she will stress this for future issues. The rn stated again that the patient is fine with no complications and supported well on the second pump. The rn does not have the serial number of the first or second pump. The css attempted to call the rn back later in the day and left a message.
 
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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 Key6058156
MDR Text Key58460544
Report Number1219856-2016-00251
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 09/30/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/26/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/31/2018
Device Catalogue NumberIAB-05840-LWS
Device Lot Number18F16G0019
Other Device ID Number00801902007247
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/08/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/22/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/11/2016
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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