MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. HEMODIALYSIS KIT: 2-L 15 FR X 23 CM; CHRONIC HEMODIALYSIS PRODUCTS

Catalog Number CS-15282-VSP

Device Problems Material Fragmentation (1261); Material Separation (1562)

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

Event Date 04/19/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that this (b)(6)/old female chronic dialysis patient had a cannon ii plus catheter in place for 5 years.In (b)(6) lab, the catheter removal procedure was performed due to bacteremia.The clinician reports that during the retrieval process, it became apparent that the cuff of the permcath had separated from the catheter itself and appeared to be in the multiple pieces, well incorporated into the patient's scar tissue.The cuff was unable to be retrieved resulting in portions of catheter cuff remain in patient subcutaneous layer.There was no reported death or complications to the patient as a result of this occurrence.The patient is doing well.

Manufacturer Narrative

Qn#(b)(4).Device evaluation: it was reported that the cannon ii plus catheter had been in situ for 5 years.In medical imaging - interventional radiology lab, the catheter removal procedure was performed due to bacteremia.The clinician reports that during the retrieval process, it became apparent that the cuff of the permcath had separated from the catheter itself and appeared to be in the multiple pieces, well incorporated into the patient's scar tissue.The cuff was unable to be retrieved resulting in portions of catheter cuff remain in patient subcutaneous layer.One chronic hemodialysis catheter was returned.The catheter cuff was not returned.The instruction booklet cautions that chronic dialysis catheters should not be used for extended use unless no other hemodialysis access options exist; they should be used only as bridge devices.The instructions for use states to use the exit site mark on catheter to ensure the cuff is positioned properly.The site maintenance procedures specify that the exit site and dressing must be kept clean and dry.A device history record review could not be performed since the lot number was not reported by the customer and could not be determined because of the length of use.Verification testing could not be performed because the other remarks: cuff was not returned for evaluation.However, based on the report that the catheter had been in situ for five years, operational context caused or contributed to this event.No further action will be taken.

• Brand Name: HEMODIALYSIS KIT: 2-L 15 FR X 23 CM
• Type of Device: CHRONIC HEMODIALYSIS PRODUCTS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNACIONAL DE CHIHUAHUA S.A. DE C.V; ave. washington 3701, edificio 4; colonia complejo industrial, las americas; chihuahua 31114 ; MX 31114
• Manufacturer Contact: jamie hartz ; 2400 bernville road; reading, PA 19605
• MDR Report Key: 5630837
• MDR Text Key: 44386546
• Report Number: 3003737899-2016-00024
• Device Sequence Number: 1
• Product Code: MSD
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K111117
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Radiologic Technologist
• Type of Report: Initial,Followup
• Report Date: 04/21/2016

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 Catalogue Number: CS-15282-VSP
• Device Lot Number: UNKNOWN
• Other Device ID Number: 00801902096388
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/21/2016
• Initial Date FDA Received: 05/04/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/27/2016
• 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 Age: 81 YR