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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ULTRAFLEX IAB: 7.5FR 40CC SYSTEM, BALLOON, INTRA-AORTIC

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ARROW INTERNATIONAL INC. ULTRAFLEX IAB: 7.5FR 40CC SYSTEM, BALLOON, INTRA-AORTIC Back to Search Results
Catalog Number IAB-06840-U
Device Problems Device Alarm System (1012); Use of Device Problem (1670)
Patient Problems Blood Loss (2597); Vascular Dissection (3160)
Event Date 05/20/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that during removal of the intra-aortic balloon (iab), resistance was met. The doctor used contrast to image the femoral artery and a dissection was noted. The doctor placed a larger sheath to help control the bleeding. The patient had adequate pulses distal to the dissection the entire time. The md consulted a vascular surgeon for repair. As a result, the patient was taken directly to the operating room for repair and is recovering well. The clinical support specialist educated and reviewed the instructions for use (ifu) with the staff and the recommendations on proper catheter removal. There was no reported patient death.
 
Manufacturer Narrative
(b)(4). Teleflex did not receive the device for investigation. Based on the event details, the reported complaint of removal difficulty is confirmed. While the product was not returned for investigation, review of the incident notes show there was an attempt to remove the iab through the sheath from the patient which is against the ifu. The teleflex clinical support specialist discussed proper iab/sheath removal with the hospital and advised to follow ifu for removal. The root cause of the complaint is undetermined. The ifu states: "do not remove arrow iab through hemostasis sheath introducer or hemostasis device. Once unwrapped (unfurled), balloon profile will not allow passage through the sheath and attempted removal in this manner may result in arterial tearing, dissection or balloon damage. " the specific serial number/lot number was not reported, but a device history record (dhr) review was conducted for the lot numbers shipped to this account with no relevant findings. All devices passed manufacturing specifications prior to release. Teleflex assessed the risk for the reported complaint. There are no new or revised risks. The reported complaint will be monitored for any developing trends. No further action required at this time.
 
Event Description
It was reported that during removal of the intra-aortic balloon (iab), resistance was met. The doctor used contrast to image the femoral artery and a dissection was noted. The doctor placed a larger sheath to help control the bleeding. The patient had adequate pulses distal to the dissection the entire time. The md consulted a vascular surgeon for repair. As a result, the patient was taken directly to the operating room for repair and is recovering well. The clinical support specialist educated and reviewed the instructions for use (ifu) with the staff and the recommendations on proper catheter removal. There was no reported patient death.
 
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Brand NameULTRAFLEX IAB: 7.5FR 40CC
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 Key7613921
MDR Text Key111480627
Report Number3010532612-2018-00172
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 05/25/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/19/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberIAB-06840-U
Device Lot NumberN/A
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 Received07/19/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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