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

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.

• Brand Name: ARROW EXT DWELL CATH DEVICE 20GAX6CM
• Type of Device: CATHETER INTRAVASCULAR THERAPE
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 7828420
• MDR Text Key: 118889499
• Report Number: 9680794-2018-00180
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: K151513
• Number of Events Reported: 1
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: EDC-00620
• Device Lot Number: 14F17J0110
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2018
• Initial Date Manufacturer Received: 08/13/2018
• Initial Date FDA Received: 08/29/2018
• Supplement Dates Manufacturer Received: 09/26/2018
• Supplement Dates FDA Received: 09/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention