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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 Fluid Leak (1250)
Patient Problems Myocardial Infarction (1969); No Consequences Or Impact To Patient (2199)
Event Date 07/10/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported via a hot line call. The rn is calling about an incident that happened yesterday ((b)(6) 2016) evening. They had placed a 40cc iab in the femoral artery without difficulty, but immediately upon starting the pump up it alarmed for helium loss, and there was blood observed in the gas tubing. They immediately removed the ruptured iab, and replaced it with another. They had no further difficulties. The rn stated that she had already spoken with the sales rep about this, and that she is only calling to report the incident. The (css) clinical support specialist first verified that they have not had any other issues since yesterday evening. The css then verified that they have kept the iab for return. The rn stated that she had no further needs or questions. The removal and replacement of the iab there was a 10 minute delay in iabp therapy reported. There were no reported patient complications and they were stable on the iabp.
 
Manufacturer Narrative
(b)(4) returned for evaluation was a 40cc 8. 0fr fos iab within its supplied return kit. The device was returned with its supplied 60cc syringe. Blood was noted on the bladder membrane, bifurcate, one-way valve, fos connector, and syringe. A kink was immediately noticeable approximately 9. 5cm from the luer end. A slight bend was noted approximately 5. 5cm from the distal tip of the catheter. Blood was noted within the short driveline tubing. The one-way valve was returned tethered to the short driveline tubing. The fos connector and cal key were examined. The gray fos connecter was properly seated in the housing and both retaining tabs were intact. The center post of the fos was centered. The blue clamshell housing was examined and no abnormalities were noted. The cal key was intact. The bladder thickness was measured at six points. 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 fos and cal key were connected to the iabp. The pump displayed a "ll pl" status indicating a potential broken fiber. The fiber was found broken approximately 1. 1 cm from the distal tip. See other remarks section. Other remarks: the iab was submerged in water and leak tested using the mdt-50. A leak was found approximately 1. 5cm from the distal tip. Under microscopic inspection, a puncture consistent with contact from the broken fiber was found. A lab inventory guidewire was inserted through the distal tip of the catheter. Resistance was noted approximately 6. 0cm from the distal tip. The guidewire could not advance. Some dried blood exited with the guidewire. The guidewire was inserted through the luer end of the catheter. Resistance was noted approximately 9. 5cm from the luer end. The guidewire could not advance. No blood or debris exited with the guidewire. The blood clot at the tip was unable to be cleared. The catheter could not be aspirated and flushed. 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. A puncture consistent with contact from the broken fiber was found near the distal tip of the catheter which likely allowed blood to enter the helium pathway. The root cause of the broken fiber is undetermined.
 
Event Description
It was reported via a hot line call. The rn is calling about an incident that happened yesterday ((b)(6) 2016) evening. They had placed a 40cc iab in the femoral artery without difficulty, but immediately upon starting the pump up it alarmed for helium loss, and there was blood observed in the gas tubing. They immediately removed the ruptured iab, and replaced it with another. They had no further difficulties. The rn stated that she had already spoken with the sales rep about this, and that she is only calling to report the incident. The (css) clinical support specialist first verified that they have not had any other issues since yesterday evening. The css then verified that they have kept the iab for return. The rn stated that she had no further needs or questions. The removal and replacement of the iab there was a 10 minute delay in iabp therapy reported. There were no reported patient complications and they were stable on the iabp.
 
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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 Key5844148
MDR Text Key51118390
Report Number1219856-2016-00168
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 07/10/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/03/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/31/2018
Device Catalogue NumberIAB-05840-LWS
Device Lot Number18F16C0040
Other Device ID Number00801902007247
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/20/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/31/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/22/2016
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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