MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW MEDICAL UNKNOWN; CATHETER, HEMODIALYSIS. IMPLANTED

Catalog Number VASCULAR UNKNOWN

Device Problems Material Frayed (1262); Sticking (1597); Detachment of Device or Device Component (2907)

Patient Problems Foreign Body In Patient (2687); No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 04/03/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Medwatch (mw5069573).No additional information was provided and there was no customer contact or facility name to reach out for additional information.

Event Description

According to the medwatch (mw5069573) "there was an attempted insertion on a patient of a dialysis catheter via the right internal jugular vein.After successful dilations, the dialysis catheter was placed over the guidewire into the vessel but the guidewire was unable to be retrieved and appeared to be stuck in the dialysis catheter.Subsequently the entire device, including the catheter and guidewire, was attempted to be removed.There appeared to be fraying of the guidewire with a piece missing.The next day the patient was returned to surgery where the retained guidewire was removed successfully and without complication by the radiologist".

Manufacturer Narrative

(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review could not be performed as the product code and lot number were not provided.Without the device to evaluate, the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

According to the medwatch (mw5069573) "there was an attempted insertion on a patient of a dialysis catheter via the right internal jugular vein.After successful dilations, the dialysis catheter was placed over the guidewire into the vessel but the guidewire was unable to be retrieved and appeared to be stuck in the dialysis catheter.Subsequently the entire device, including the catheter and guidewire, was attempted to be removed.There appeared to be fraying of the guidewire with a piece missing.The next day the patient was returned to surgery where the retained guidewire was removed successfully and without complication by the radiologist".

• Brand Name: ARROW MEDICAL UNKNOWN
• Type of Device: CATHETER, HEMODIALYSIS. IMPLANTED
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 312 commerce place; asheboro NC 27203
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334854
• MDR Report Key: 6656454
• MDR Text Key: 78044512
• Report Number: 1036844-2017-00251
• Device Sequence Number: 1
• Product Code: MSD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 06/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: VASCULAR UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/31/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention