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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC KIT: 3-LUMEN 7 FR X 16 CM CATHETER INTRAVASCULAR THERAPE

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ARROW INTERNATIONAL INC. ARROW CVC KIT: 3-LUMEN 7 FR X 16 CM CATHETER INTRAVASCULAR THERAPE Back to Search Results
Catalog Number AK-42703-CDC
Device Problems Break (1069); Difficult to Advance (2920); Migration (4003)
Patient Problems No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)
Event Date 05/21/2020
Event Type  Injury  
Manufacturer Narrative
Qn # (b)(4). The following additional information was provided by the user facility: on initial placement of cvc, in the subclavian vessel, the user had some difficulty with insertion. A second kit was used , and placement was successful. After insertion the patient was transferred to a higher level of care. This transfer was un-related to cvc placement. A ct scan was ordered (un-related to cvc placement) and it was noted that a fragment of the guide was in a pelvic vessel. A procedure was performed to remove the fragment. Fragment removed without incident. Patient did not experience any complication or change in health status as a result of this event. Hospital stay was not prolonged as a result of this event.
 
Event Description
The customer reports: unknown to the inserter a broken piece of the wire found post insertion following a transfer to the incoming facility. While it was being placed in a patient the guide wire broke off and migrated to the patient's pelvic vessel. The patient had an additional procedure to remove fragment. Physician had difficulty advancing the catheter on first attempt and aborted and as a result second kit pulled re-accessed with success. Rt subclavian approach second attempt successful.
 
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Brand NameARROW CVC KIT: 3-LUMEN 7 FR X 16 CM
Type of DeviceCATHETER INTRAVASCULAR THERAPE
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
Manufacturer (Section G)
ARROW INTERNATIONAL DE MEXICO S.A. DE C.V.
ave. washington 3701
colonia panamericana, chihuahua
chihuahua 31200
MX 31200
Manufacturer Contact
katharine tarpley
3015 carrington mill blvd
morrisville, NC 27560
9194334854
MDR Report Key10122790
MDR Text Key194120705
Report Number9680794-2020-00268
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K993691
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 05/22/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/05/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/30/2020
Device Catalogue NumberAK-42703-CDC
Device Lot Number13F19A0309
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/08/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/10/2019
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: 06/05/2020 Patient Sequence Number: 1
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