MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW MULTI-LUMEN CVC KIT: 2-L 7 FR X 8"; CATHETER, PERCUTANEOUS

Catalog Number SA-17702-J

Device Problem Material Separation (1562)

Patient Problem Death (1802)

Event Date 08/13/2020

Event Type  Death  

Manufacturer Narrative

Qn# (b)(4).The sales rep.Attempted to obtain additional information from the user facility.The user facility refused submitting any additional information.Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed, and no relevant findings were identified.Based on the customer report, "self-removal of the catheter by the patient caused damage to one of extension lines," user error likely caused or contributed to this event.However, without the device to evaluate, the complaint could not be confirmed, and the probable cause could not be determined from the available information.Corrective action is not required at this time as the probable cause could not be determined based upon the information provided and without a sample.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

It was reported: self-removal of the catheter by the patient caused damage to one of the extension lines.The extension line detached from the injection hub, and the relationship is unknown though, the patient was eventually deceased.The user suspects the air embolism became the cause of the patient's death.

Event Description

It was reported: self removal of the catheter by the patient caused damage to one of the extension lines.The extension line detached from the injection hub, and the relationship is unknown though, the patient was eventually deceased.The user suspects the air embolism became the cause of the patient's death.The sales rep.Attempted to obtain additional information from the user facility.The user facility refused submitting any additional information.

Manufacturer Narrative

(b)(4).The customer returned one product lidstock and 2-lumen cvc for evaluation.The catheter contained a suture on one wing and obvious signs of use in the form of biological material.Visual examination revealed the distal lumen was separated from the juncture hub.The lumen appeared to be significantly stretched and thinned.The writing of "distal 14ga" on the lumen was elongated.The separated location on the juncture hub also contained minor damage.The total length of the catheter body measured to be 214 mm which is within specifications of 207-227 mm per product drawing.The total length of the separated distal lumen measured to be 118 mm which is not consistent with the nominal value of 86 mm per product drawing.This confirms that the lumen was significantly stretched.The outer diameter of the distal lumen measured to be 1.99 mm which is not within specifications of 2.39-2.49 mm per product drawing.This also indicates that the lumen was severely stretched.The inner diameter of the distal lumen measured to be 1.75 mm which is within specifications of 1.65-1.75 mm per product drawing.The proximal lumen was flushed using a water-filled lab inventory syringe.No blockages or leaks were detected.A manual tug test confirmed the proximal lumen was fully secured within the catheter juncture hub.A device history record review was performed with no relevant findings.The instructions-for-use provided with this kit warns the user, "do not apply excessive force in removing guide wire or catheters.If withdrawal cannot be easily accomplished, a chest x-ray should be obtained and further consultation requested." the customer report of a separated extension line was confirmed by complaint investigation of the returned sample.The distal lumen was separated adjacent to the juncture hub.The separated extension line was stretched and thinned which indicates undue force caused or contributed to the breakage.A device history record review was performed with no relevant findings.Based on the condition of the sample received, unintentional user error caused or contributed this event.Teleflex will continue to monitor and trend for complaints of this nature.

• Brand Name: ARROW MULTI-LUMEN CVC KIT: 2-L 7 FR X 8"
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 10488362
• MDR Text Key: 205501506
• Report Number: 3006425876-2020-00769
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 08/31/2021
• Device Catalogue Number: SA-17702-J
• Device Lot Number: 71F19J0182
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2020
• Date Manufacturer Received: 09/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN.; UNKNOWN.
• Patient Outcome(s): Death