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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. NARROWFLEX IAB: 8FR 30CC SYSTEM, BALLOON, INTRA-AORTIC

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ARROW INTERNATIONAL INC. NARROWFLEX IAB: 8FR 30CC SYSTEM, BALLOON, INTRA-AORTIC Back to Search Results
Catalog Number IAB-04830-U
Device Problems Device Alarm System (1012); Fluid Leak (1250); Material Rupture (1546)
Patient Problems Death (1802); Multiple Organ Failure (3261)
Event Date 10/20/2017
Event Type  Death  
Manufacturer Narrative
(b)(4). Teleflex received the device for investigation. The reported complaint of blood in the helium pathway is confirmed. The bladder had a full thickness abrasion which allowed blood to enter the iab. The appearance of the abraded area is consistent with repeated contact with calcified plaque on the aortic wall. 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. Teleflex assessed the risk for the reported complaint and there are no new or revised risks. (b)(4). Additional information received: according to the doctor, dr. (b)(6) this device did not cause or contribute to the patient's death.
 
Event Description
The intra-aortic balloon was inserted into a patient of 143cm in height and it was reported that after the pump alarmed "gas leak", blood appeared in the pressure tubing, blood in the balloon visible after removing the catheter. It was reported that the patient expired and therapy was delayed and interrupted. It is unknown if the device caused harm to the patient but per the report "balloon filling has been reduced".
 
Manufacturer Narrative
(b)(4).
 
Event Description
The intra-aortic balloon was inserted into a patient of (b)(6) in height and it was reported that after the pump alarmed "gas leak", blood appeared in the pressure tubing, blood in the balloon visible after removing the catheter. It was reported that the patient expired and therapy was delayed and interrupted. It is unknown if the device caused harm to the patient but per the report "balloon filling has been reduced".
 
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Brand NameNARROWFLEX IAB: 8FR 30CC
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
Manufacturer (Section G)
ARROW INTERNATIONAL INC.
16 elizabeth drive
chelmsford MA 01824
Manufacturer Contact
carmen sherman
16 elizabeth drive
chelmsford, MA 01824
9782505100
MDR Report Key6991032
MDR Text Key105937988
Report Number1219856-2017-00278
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodePL
PMA/PMN Number
K993966
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/24/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/31/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date08/31/2018
Device Catalogue NumberIAB-04830-U
Device Lot Number18F16H0001
Other Device ID Number00801902002631
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/22/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/15/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/01/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 10/31/2017 Patient Sequence Number: 1
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