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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. FIBEROPTIX ULTRA 8 IAB: 8FR 30CC INTRA- AORTIC BALLOON FIBER OPTIC

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ARROW INTERNATIONAL INC. FIBEROPTIX ULTRA 8 IAB: 8FR 30CC INTRA- AORTIC BALLOON FIBER OPTIC Back to Search Results
Catalog Number IAB-05830-LWS
Device Problem Material Rupture (1546)
Patient Problems Myocardial Infarction (1969); Cardiogenic Shock (2262)
Event Date 06/21/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported via a hotline call. The rn from the (ccu) cardiac care unit has a 5'0" in height patient that was on (iabp) intra-aortic balloon pump therapy. The rn stated she noticed 1-2 specks of dark brown material in helium tubing and it increased over the last half an hour. The patient has a (ci) cardiac index of 1. 2 but putting out 100-200 ml. Urine. The pump (s/n (b)(4)) did have possible helium loss alarms, but resumed pumping. The (css) clinical support specialist instructed the rn to stop pumping, clamp the tubing, and disconnect from the pump and call someone to remove the iab as soon as possible because there is a hole in the iab. The rn put the css on hold and came back on and said the surgeon was there and he did not want to stop pumping. The css asked to speak to the surgeon. The surgeon told the css, "we cannot just stop pumping. " the css explained that the iab had a hole in it and it needed to come out asap. The surgeon reiterated that he did not want to stop pumping. The css stated the risk of helium in the vascular system and the blood in the catheter can clot and the iab may have difficulty being removed. The surgeon agreed and told the rn to stop pumping. The css spoke to the rn again, and told her to please save the iab and make sure the pump is sent to biomed to be checked for blood contamination. The rn was not sure if they would insert another iab. An additional call placed @ 0610 cdt: the css called the rn back to see how the removal went and how the patient was. The rn stated the iab was removed without difficulty and it was very bloody, but they had it in a bag for return. The rn stated the patient was hemodynamically the same, and her drugs were at the same dosages with the addition of milrinone @ 0. 25 mcg. The point in the procedure when the difficulty was met was ~ 1 hour after insertion. Outcome of patient: patient stable on support drugs.
 
Manufacturer Narrative
(b)(4) no product was returned for evaluation. 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 not able to be confirmed. No product was returned for evaluation. The root cause of the complaint is undetermined.
 
Event Description
It was reported via a hotline call. The rn from the (ccu) cardiac care unit has a (b)(6) height patient that was on (iabp) intra-aortic balloon pump therapy. The rn stated she noticed 1-2 specks of dark brown material in helium tubing and it increased over the last half an hour. The patient has a (ci) cardiac index of 1. 2 but putting out 100-200 ml. Urine. The pump (s/n (b)(4)) did have possible helium loss alarms, but resumed pumping. The (css) clinical support specialist instructed the rn to stop pumping, clamp the tubing, and disconnect from the pump and call someone to remove the iab as soon as possible because there is a hole in the iab. The rn put the css on hold and came back on and said the surgeon was there and he did not want to stop pumping. The css asked to speak to the surgeon. The surgeon told the css, "we cannot just stop pumping. " the css explained that the iab had a hole in it and it needed to come out asap. The surgeon reiterated that he did not want to stop pumping. The css stated the risk of helium in the vascular system and the blood in the catheter can clot and the iab may have difficulty being removed. The surgeon agreed and told the rn to stop pumping. The css spoke to the rn again, and told her to please save the iab and make sure the pump is sent to biomed to be checked for blood contamination. The rn was not sure if they would insert another iab. An additional call placed @ 0610 cdt: the css called the rn back to see how the removal went and how the patient was. The rn stated the iab was removed without difficulty and it was very bloody, but they had it in a bag for return. The rn stated the patient was hemodynamically the same, and her drugs were at the same dosages with the addition of milrinone @ 0. 25 mcg. The point in the procedure when the difficulty was met was ~ 1 hour after insertion. Outcome of patient: patient stable on support drugs.
 
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Brand NameFIBEROPTIX ULTRA 8 IAB: 8FR 30CC
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 Key5792176
MDR Text Key49501992
Report Number1219856-2016-00153
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 06/21/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/13/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/31/2017
Device Catalogue NumberIAB-05830-LWS
Device Lot Number18S15H0051
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/04/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/18/2016
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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