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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW EXT DWELL CATH DEVICE 20GAX6CM CATHETER INTRAVASCULAR THERAPE

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ARROW INTERNATIONAL INC. ARROW EXT DWELL CATH DEVICE 20GAX6CM CATHETER INTRAVASCULAR THERAPE Back to Search Results
Catalog Number EDC-00620
Device Problem Material Fragmentation (1261)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 08/10/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
The customer reports: vascular access team went to a patient's bedside to place an extended dwell catheter for 7-10 days of antibiotics. Upon insertion under ultrasound guidance the 4 cm wire advanced without difficultly, then when the catheter was advanced resistance was met. The catheter was then removed and set aside. The vascular access nurse noticed that the end of the endurance catheter was missing approximately 2. 5 cm. The patient was re-examined using ultrasound and the tip of the catheter was found in the cephalic vein. Patient was then sent to surgery to have the tip removed via subcutaneous take down.
 
Event Description
The customer reports: vascular access team went to a patient's bedside to place an extended dwell catheter for 7-10 days of antibiotics. Upon insertion under ultrasound guidance the 4cm wire advanced without difficultly, then when the catheter was advanced resistance was met. The catheter was then removed and set aside. The vascular access nurse noticed that the end of the endurance catheter was missing approximately 2. 5cm. The patient was re-examined using ultrasound and the tip of the catheter was found in the cephalic vein. Patient was then sent to surgery to have the tip removed via subcutaneous take down.
 
Manufacturer Narrative
(b)(4). The customer returned a catheter assembly from an endurance device for evaluation. The catheter was returned detached from the endurance device and the catheter body was separated in two pieces near the distal end. In addition, the needle guard was on the distal end of the introducer needle. Visual examination of the separation point of the catheter revealed both separated edges were smooth, which is consistent with damage resulting from contact with the needle bevel. Dried blood was observed within the catheter body but no other damage to the catheter was observed. The proximal end of the separated catheter body measured 1. 61417" in length and the distal end of the separated catheter body measured. 984252" in length (approximately 2. 598" total). The catheter length specification is 2. 594"-2. 604" per catheter drawing; therefore, the catheter met the original length specifications. The catheter body inner and outer diameter was also within specification. The catheter was flushed with water and functioned as expected. A device history record review was performed and no manufacturing issues were identified. The current instructions-for-use (ifu) provided with this kit gives instructions for proper techniques while inserting the catheter. It cautions the user to "always keep needle/handle stationary while threading catheter. Do not retract needle/handle while threading catheter. Failure to keep needle/ handle stationary may prevent catheter from threading into vessel. " the ifu also cautions "do not force catheter if resistance is encountered during advancement. " the customer report that the catheter body separated was confirmed through visual examination of the returned sample. The catheter body was returned separated in two pieces and the separation point was consistent with damage due to contact with the needle bevel. The catheter met all relevant dimensional requirements and no manufacturing issues were identified during a device history record review. Based on the condition of the returned sample and the customer report, it was determined that operational context caused or contributed to this event. Teleflex will continue to monitor and trend for reports of this nature.
 
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Brand NameARROW EXT DWELL CATH DEVICE 20GAX6CM
Type of DeviceCATHETER INTRAVASCULAR THERAPE
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key7828420
MDR Text Key118889499
Report Number9680794-2018-00180
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
PMA/PMN Number
K151513
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 08/13/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/29/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberEDC-00620
Device Lot Number14F17J0110
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/10/2018
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/26/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 08/29/2018 Patient Sequence Number: 1
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