MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW HEMODIALYSIS SET: 2-L 15 FR X 27 CM; CATHETER, HEMODIALYSIS, IMPLA

Catalog Number CS-15272-VFI

Device Problem Detachment of Device or Device Component (2907)

Patient Problems No Consequences Or Impact To Patient (2199); Device Embedded In Tissue or Plaque (3165)

Event Date 11/28/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer reports: "account reported patient was referred to ir lab for dialysis catheter exchange.Upon initial inspection it was noted that the original clamps had been removed and new clamps added.During removal of the catheter the cuff became detached from the catheter and remained in the subcutaneous tissue.The cuff was not retrievable and the operator proceeded with the exchange and placed a new vectorflow catheter in the patient through same site.No further intervention was required".There was no patient injury or consequence.The patient's condition is reported as "fine".Therapy was not delayed or interrupted.

Manufacturer Narrative

(b)(4).The customer returned one hemodialysis catheter for investigation.The catheter cuff was not returned.A visual examination was performed and biological material was found on the entire device exterior in the form of blood.Microscopic examination confirmed adhesive on the catheter body extrusion.The adhesive material also had fibrous material stuck to it.The lot number was not reported; therefore, a device history record review was performed based on the sales history of the customer.No relevant findings were identified.The instructions for use (ifu) provided with this kit states "cut catheter between clamp and exit site, remove internal portion of catheter through cuff incision site.Check catheter integrity for tears.Measure catheter when removed; it must be equal to length of catheter when inserted.Inspect for entire cuff".The reported complaint of a catheter cuff separating from the catheter body was confirmed by complaint investigation.The catheter cuff was not returned.The catheter body extrusion contained adhesive material where the catheter cuff was, indicating manufacturing correctly assembled the cuff.No other anomalies or abnormalities were observed.Based on the sample received, it was determined that operational context caused or contributed to this event.Teleflex will continue to monitor and trend for complaints of this nature.

Event Description

The customer reports: "account reported patient was referred to ir lab for dialysis catheter exchange.Upon initial inspection it was noted that the original clamps had been removed and new clamps added.During removal of the catheter the cuff became detached from the catheter and remained in the subcutaneous tissue.The cuff was not retrievable and the operator proceeded with the exchange and placed a new vectorflow catheter in the patient through same site.No further intervention was required".There was no patient injury or consequence.The patient's condition is reported as "fine".Therapy was not delayed or interrupted.

• Brand Name: ARROW HEMODIALYSIS SET: 2-L 15 FR X 27 CM
• Type of Device: CATHETER, HEMODIALYSIS, IMPLA
• 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: 7087913
• MDR Text Key: 93889054
• Report Number: 1036844-2017-00441
• Device Sequence Number: 1
• Product Code: MSD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141051
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: CS-15272-VFI
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/22/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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