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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ULTRAFLEX IAB: 7.5FR 40CC INTRA- AORTIC BALLOOON PRODUCTS

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ARROW INTERNATIONAL INC. ULTRAFLEX IAB: 7.5FR 40CC INTRA- AORTIC BALLOOON PRODUCTS Back to Search Results
Catalog Number IAB-06840-U
Device Problem Fluid Leak (1250)
Patient Problems Cardiopulmonary Arrest (1765); Cognitive Changes (2551); Blood Loss (2597)
Event Date 08/14/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Sample not returned to manufacturer.
 
Event Description
It was reported that the event involved a patient 178cm in height in for a ventricular assist device (vad) workup. Originally, the catheter was placed via the femoral, later changed (b)(6) to axillary to provide ambulation for patient. Patient experienced gushing blood in balloon catheter tubing, (competitors) pump was removed from service due to likely bleed back in to pump. The customer was not aware of gas loss alarm before or after. The gas loss alarm may alert the registered nurse to blood in the catheter. The catheter was replaced within 30 minutes. The next iab was inserted via the patient's left axillary using the arrow flex sheath. The insertion was successful. There was no reported patient death or injury. The complications were described as "the patient was required to undergo additional procedure with sedation to removal and replacement the balloon catheter. Pump strips were generated and are not available for review. X-rays were performed daily and are not available for review. The interruption in iabp therapy is listed as 30 minutes.
 
Manufacturer Narrative
Qn#(b)(4). No product was returned for evaluation. A device history record (dhr) review was conducted for the serial/lot 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 that the event involved a patient 178cm in height in for a ventricular assist device (vad) workup. Originally, the catheter was placed via the femoral, later changed ((b)(6)) to axillary to provide ambulation for patient. Patient experienced gushing blood in balloon catheter tubing, (competitors) pump was removed from service due to likely bleed back in to pump. The customer was not aware of gas loss alarm before or after. The gas loss alarm may alert the registered nurse to blood in the catheter. The catheter was replaced within 30 minutes. The next iab was inserted via the patient's left axillary using the arrow flex sheath. The insertion was successful. There was no reported patient death or injury. The complications were described as "the patient was required to undergo additional procedure with sedation to removal and replacement the balloon catheter. Pump strips were generated and are not available for review. X-rays were performed daily and are not available for review. The interruption in iabp therapy is listed as 30 minutes.
 
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Brand NameULTRAFLEX IAB: 7.5FR 40CC
Type of DeviceINTRA- AORTIC BALLOOON PRODUCTS
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 Key5939508
MDR Text Key54323567
Report Number1219856-2016-00198
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K000729
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 08/15/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/09/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/30/2017
Device Catalogue NumberIAB-06840-U
Device Lot Number18F15J0056
Other Device ID Number00801902026804
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 Received10/05/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/29/2015
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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