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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW MAC KIT: 2-L 9 FR DISTAL X 11.5 CM CATHETER,INTRAVASCULAR,THERAP

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ARROW INTERNATIONAL INC. ARROW MAC KIT: 2-L 9 FR DISTAL X 11.5 CM CATHETER,INTRAVASCULAR,THERAP Back to Search Results
Catalog Number ASK-21242-DU
Device Problems Labelling, Instructions for Use or Training Problem (1318); Mechanical Problem (1384)
Patient Problems Stroke/CVA (1770); Embolism (1829)
Event Date 08/19/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4). Potential lot# - 23f17b0115. All three events captured in the following mdrs: mdr #1036844-2020-00120 (limb amputation), mdr #1036844-2020-00118 (stroke & death).
 
Event Description
The information is reported by the doctor as: i am writing to share concerns about device safety with the arrowg+ard blue mac catheter. We have observed 3 similar cases in the past year in our institution associated with this device, resulting in 3 arterial injuries, 2 strokes, one limb amputation, and one death. Our subsequent simulation of the device insertion demonstrated that the dilator can puncture the posterior vessel wall, potentially damaging adjacent structures, when the guidewire is not inserted to sufficient depth. Under these conditions, the sharp tip of the dilator is not protected by protruding guidewire and can directly contact and penetrate the posterior vessel wall. Without sufficient wire to guide it, the dilator follows a straight trajectory from the skin surface, increasing the likelihood that it will penetrate the posterior vessel wall, rather than following the vessel lumen. The kit instructions do not provide instructions on appropriate guidewire insertion depth, and the guidewire is not marked to indicate appropriate insertion depth. The 45cm guidewire provided in the kit may contribute to the risk of this complication; a longer (60cm) guidewire is provided in your triple- lumen catheter kit. The 45cm guidewire does not provide sufficient length within the target vessel if the operator allows greater than approximately 10cm of guidewire external to the patient, to prevent the wire from embolizing into the patient. The doctor reports that this patient was discharged to an outpatient subacute rehabilitation facility and neurologic deficits largely resolved.
 
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Brand NameARROW MAC KIT: 2-L 9 FR DISTAL X 11.5 CM
Type of DeviceCATHETER,INTRAVASCULAR,THERAP
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
Manufacturer (Section G)
ARROW INTERNATIONAL INC.
312 commerce place
asheboro NC 27203
Manufacturer Contact
katharine tarpley
3015 carrington mill blvd
morrisville, NC 27560
9194334854
MDR Report Key9865371
MDR Text Key188215214
Report Number1036844-2020-00119
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K011761
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 03/07/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/23/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberASK-21242-DU
Device Lot NumberUNKNOWN
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 Received04/21/2020
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: 03/23/2020 Patient Sequence Number: 1
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