MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW VASCULAR UNKNOWN; CATHETER, PERCUTANEOUS

Catalog Number VASCULAR UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Injury (2348); Device Embedded In Tissue or Plaque (3165); No Information (3190)

Event Date 09/06/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Contact information: unknown as this information was not provided on the medwatch.The customer cannot be reached for inquiries regarding the reported serious injury or required intervention.If contact information is provided then the customer will be contacted for additional information.

Event Description

According to the medwatch (mw5076917) "pt with sepsis required central line placement.The catheter was placed without difficulty in the right internal jugular vein.Imaging to confirm placement showed that the entire guidewire had been retained with the end of the guidewire extending down into the superficial femoral vein.The guidewire was successfully removed in interventional radiology without incident".The report completed by a nurse states there was a serious injury and intervention was required.However, there was no mention of a specific injury or intervention that was performed.

Event Description

According to the medwatch (mw5076917) "pt with sepsis required central line placement.The catheter was placed without difficulty in the right internal jugular vein.Imaging to confirm placement showed that the entire guidewire had been retained with the end of the guidewire extending down into the superficial femoral vein.The guidewire was successfully removed in interventional radiology without incident".The report completed by a nurse states there was a serious injury and intervention was required.However, there was no mention of a specific injury or intervention that was performed.

Manufacturer Narrative

(b)(4).Medwatch# mw5076917.Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review could not be performed since a correct material and lot number was not provided by the customer in the medwatch report.Based on the report that the guide wire was left in the patient, the root cause of this complaint is user error.An in-service request could not be initiated as no customer information was reported on the medwatch.Teleflex will continue to monitor and trend for complaints of this nature.

• Brand Name: ARROW VASCULAR UNKNOWN
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 7540506
• MDR Text Key: 109140903
• Report Number: 1036844-2018-00165
• 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: health professional,other,use
• Type of Report: Initial,Followup
• Report Date: 05/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: VASCULAR UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: N/A.