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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW EXT DWELL CATH BASIC 20GAX8CM CATHETER INTRAVASCULAR THERAPE

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ARROW INTERNATIONAL INC. ARROW EXT DWELL CATH BASIC 20GAX8CM CATHETER INTRAVASCULAR THERAPE Back to Search Results
Catalog Number EDC-00820-B
Device Problems Material Separation (1562); Physical Resistance (2578)
Patient Problems No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)
Event Date 11/15/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4). The customer returned one 20 ga endurance catheter device for evaluation. The catheter for the device showed evidence of use and the catheter body was torn/separated near the distal end. Both sections were returned. Visual examination revealed the catheter body was torn/separated on the distal end. Microscopic examination revealed the point of separation had smooth edges, which indicates the catheter was cut using a sharp object. The proximal end of the separated catheter body measured 73 mm in length and the distal end of the separated catheter body measured 12 mm in length. The catheter length specification is 84. 86- 85. 12mm; therefore, the catheter met the original length specifications. A device history record review was performed on the catheter and no relevant findings were identified. The product's instructions for use (ifu) included with the kit, was reviewed for this investigation. The ifu warns the end user to not attempt to advance needle back into catheter after catheter is partially threaded off needle to reduce risk of catheter damage. It also warns that if resistance is met, do not apply excessive force in removing the needle/guidewire. Remove system as a unit. The reported complaint of the catheter being torn into two pieces was confirmed by visual examination of the returned sample. The catheter body was separated on the distal end of the catheter. Microscopic examination found the separation point of the catheter body had smooth edges which indicate the catheter was separated due to contact with a sharp object. The customer reported that the catheter was sheared of by the needle bevel when the clinician pulled back on the guidewire and catheter due to resistance. However, the ifu warns the end user to not attempt to advance needle back into catheter after catheter is partially threaded off the needle to reduce risk of catheter damage. It also warns that if resistance is met, do not apply excessive force in removing the needle/guidewire. Remove system as a unit. Based on the investigation findings and information provided by the customer, it was determined that operational context caused or contributed to this event.
 
Event Description
The customer reports "upon inserting the endurance catheter there was resistance so the clinician pulled back on the guide wire and then pulled back on the catheter which caused the bevel of the needle to shear of 1cm off the catheter in to the patient's arm. The piece of catheter was in the tissue of the arm so a physician had to come in to cut out the piece. The patient is in stable condition". The patient was reported to be "fine". Therapy was stated to be delayed/interrupted as a result of the alleged defect.
 
Manufacturer Narrative
(b)(4).
 
Event Description
The customer reports "upon inserting the endurance catheter there was resistance so the clinician pulled back on the guide wire and then pulled back on the catheter which caused the bevel of the needle to shear of 1cm off the catheter in to the patient's arm. The piece of catheter was in the tissue of the arm so a physician had to come in to cut out the piece. The patient is in stable condition". The patient was reported to be "fine". Therapy was stated to be delayed/interrupted as a result of the alleged defect.
 
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Brand NameARROW EXT DWELL CATH BASIC 20GAX8CM
Type of DeviceCATHETER INTRAVASCULAR THERAPE
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 Key7071793
MDR Text Key258049224
Report Number1036844-2017-00429
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K163513
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 11/15/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/30/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/30/2019
Device Catalogue NumberEDC-00820-B
Device Lot Number13F17F0740
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/11/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/12/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/29/2017
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: 11/30/2017 Patient Sequence Number: 1
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