MAUDE Adverse Event Report: ARROW INTERNATIONAL, INC. (SUBSIDIARY OF TELEFLEX, INCORPORATED) ARROW HEMODIALYSIS CATHETER; CATHETER, HEMODIALYSIS, NON-IMPLANTED

Model Number CDC-25142-X1A

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/23/2021

Event Type  Injury  

Event Description

Arrowgard blue two-lumen hemodialysis catheterization kit for high volume infusions 14f, 2 lumen, 20 cm with 0.35 inch dia.Spring-wire guide.Insertion of guide-wire was uneventful.Catheter was then inserted but there was difficulty removing guidewire approximately half way.Upon initial inspection of guidewire, it appeared intact but once x-ray was completed it was noted that a piece of the guidewire was retained inside of the patient's vasculature.Interventional radiology was notified and was able to remove the remaining guidewire.Chest xr addendum: additional clinical history provided of retained wire.There is a new linear density projecting over the right neck with tip in the right svc which could reflect retained wire.Correlate clinically.Ct chest w/o contrast: linear metallic density in the right neck soft tissues extending into the right internal jugular vein with tip in the svc compatible with reported history of retained wire.The proximal aspect of the wire is not included in the field-of-view.Ir removal: impression: status post successful removal of foreign body under fluoroscopic guidance.Fda safety report id# (b)(4).

• Brand Name: ARROW HEMODIALYSIS CATHETER
• Type of Device: CATHETER, HEMODIALYSIS, NON-IMPLANTED
• Manufacturer (Section D): ARROW INTERNATIONAL, INC. (SUBSIDIARY OF TELEFLEX, INCORPORATED)
• MDR Report Key: 12121432
• MDR Text Key: 260548282
• Report Number: MW5102293
• Device Sequence Number: 1
• Product Code: MPB
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/30/2021

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 Expiration Date: 10/31/2021
• Device Model Number: CDC-25142-X1A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/02/2021
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR
• Patient Weight: 168