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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 SYSTEM, BALLOON, INTRA-AORTIC

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ARROW INTERNATIONAL INC. FIBEROPTIX ULTRA 8 IAB: 8FR 40CC SYSTEM, BALLOON, INTRA-AORTIC Back to Search Results
Model Number IPN000254
Device Problem Material Perforation (2205)
Patient Problem Ischemia (1942)
Event Date 03/03/2021
Event Type  Injury  
Manufacturer Narrative
(b)(6).
 
Event Description
Complaint was received via medwatch ((b)(4)). Fracture intra-aortic balloon pump (iabp) retained in right femoral artery causing acute limb ischemia in the right lower extremity; required emergent return to or for cut-down of right femoral artery. Device was placed at holy redeemer hospital prior to patient being flown to doylestown hospital for acute stemi and emergent cath lab intervention on 03mar2021. Additional information received from (b)(6) hospital on 19apr2021: the patient arrived in the cvicu from (b)(6) hospital with the catheter and arrow iabp in place. Shortly after arrival, he was transported to the ccl for an intervention: atherectomy and stent. The iabp was converted over to our pump which is a cs 300 datascope (getinge) upon his arrival in cvicu. There was no blood in the tubing on arrival or at any time during the attempted removal. Initially, the patient was stable without any alarms on the pump when he arrived in cvicu as well as after his return from the ccl. During the night, at approximately 0400 he began to complain of severe abdominal pain. At this time, the pump alarmed "leak in circuit". The nurse contacted the getinge rep on call who advised to hold the fill button for 2 seconds and then restart the pump. This was done, but within minutes, the leak in circuit alarmed again and despite refilling the balloon, the alarms continued. By 0445 the cs 300 datascope (getinge) pump was basically non-functional and was placed on standby. The interventional cardiologist arrived shortly after to remove the catheter. By 0630 the patient was transferred to the vascular lab for an emergent cut down and removal of the catheter. A femoral endarterectomy and balloon angioplasty was done on the right femoral artery. Randy guess, biomed engineer, is not aware of whether or not there is an alarm history in the pump, but he is going to check into that. The patient was discharged home and is doing well.
 
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Brand NameFIBEROPTIX ULTRA 8 IAB: 8FR 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
kaylia pen
2400 bernville road
reading, PA 19605
MDR Report Key11718474
MDR Text Key249680413
Report Number3010532612-2021-00095
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 health professional,user faci
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/24/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/23/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberIPN000254
Device Catalogue NumberIAB-05840-LWS
Device Lot Number18F20M0070
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/23/2021
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/13/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/23/2020
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: 04/23/2021 Patient Sequence Number: 1
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