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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC KIT CATHETER INTRAVASCULAR THERAPE

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ARROW INTERNATIONAL INC. ARROW CVC KIT CATHETER INTRAVASCULAR THERAPE Back to Search Results
Catalog Number VASCULAR UNKNOWN
Device Problem Biocompatibility (2886)
Patient Problem Anaphylactic Shock (1703)
Event Date 06/16/2021
Event Type  Injury  
Manufacturer Narrative
Qn#: (b)(4).
 
Event Description
Customer reports a suspected allergic reaction to an arrow catheter: "a (b)(6) year old lady who had suffered a gynecological malignancy and underwent a pelvic exenteration in 1991, which included a cystectomy with an indiana pouch formation. She has had ongoing issues with ureteroenteric strictures causing urosepsis requiring icu admissions, and chronic bilateral hydronephrosis resulting in chronic kidney disease with an estimated gfr of 27. She had elected to have surgery for a revision of the ureteric anastamosis to improve kidney function. " "the patient was brought into the operating room and under chlorhexidine skin preparation a thoracic epidural, and radial arterial line were placed. Anesthesia induced uneventfully. Then a right internal jugular line placed. Shortly after a rash developed along arms and face. Then developed a decrease in blood pressure, which required an epinephrine infusion of 15 mcg/min to maintain a mean arterial pressure of 65 mm hg. Her troponin peaked at 3. 3 and at 24 hours was 1. 2. " it was reported surgery was aborted. Patient condition reported to be fine. Patient developed a mild troponin rise of 31 to 96. Lab normal is less than 51. Subsequent myocardial perfusion scan revealed no inducible ischemia. The patient is still waiting for a revision ureteric anastomosis with decrease renal function. Formal allergy testing is pending.
 
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Brand NameARROW CVC KIT
Type of DeviceCATHETER INTRAVASCULAR THERAPE
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key12578240
MDR Text Key274904295
Report Number9680794-2021-00499
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 09/13/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/05/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberVASCULAR UNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/02/2021
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

Patient Treatment Data
Date Received: 10/05/2021 Patient Sequence Number: 1
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