MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 5-LUMEN 9.5FR X 16CM; CATHETER, PERCUTANEOUS

Catalog Number DE-12955-S

Device Problem Split (2537)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/28/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device not sold in the us.Similar device sold in us.The customer complaint form indicates that there was no patient injury and no medical/surgical intervention required.

Event Description

The customer reports that during insertion the dilator tip got damaged (split).Part of the dilator remained into the patient's tissue.A new dilator was used successfully.The patient's condition is reported as fine.Additional information received indicates that pieces of the broken dilator are the patient's tissue.An x-ray was performed which showed no fragments.

Manufacturer Narrative

(b)(4).The customer returned a dilator with a white hub.With the unaided eye, the dilator tip was bent and a portion of the tip was missing.Under microscopic examination, a piece of the tip measuring approximately 0.5cm in length and 3/4 the circumference of the tip was missing.The region where the piece was missing appeared torn.There were white regions on the edges of the separation and at the location of the bend.The inside of the tip had the impression of a guide wire on one of the sides where it had separated.The white regions and the impression of the guide wire are indications that the tip of the dilator was subjected to stress.The length of the dilator body was measured and found to be within specification.The outside diameter (od) of the dilator body measured 3.47mm which met specification.A review of the device history records (dhr) for the catheter did not reveal any manufacturing related issues.The ifu provided with the kit describes an insertion procedure including the step to enlarge the cutaneous puncture site with the cutting edge of a scalpel if necessary.The customer did not report whether or not this step was performed.Other remarks: the report that the dilator tip was damaged and split during insertion was confirmed through examination of the returned sample.The dilator tip was bent and a piece of the tip approximately 0.5cm in length and 3/4 the circumference of the tip was missing.The inside of the tip had the impression of the guide wire on one of the sides where it had separated.A dhr review was performed and it did not reveal any manufacturing related issues.Based on the torn appearance of the dilator tip and the report that the damage occurred during insertion, it was determined that operational context caused or contributed to this event.

Event Description

The customer reports that during insertion the dilator tip got damaged (split).Part of the dilator remained into the patient's tissue.A new dilator was used successfully.The patient's condition is reported as fine.Additional information received indicates that pieces of the broken dilator are the patient's tissue.An x-ray was performed which showed no fragments.

• Brand Name: ARROW CVC SET: 5-LUMEN 9.5FR X 16CM
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL CR, A.S.; jamska 2359/47; zdar nad sazavou 591 0 1; EZ 591 01
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334854
• MDR Report Key: 6471791
• MDR Text Key: 72177660
• Report Number: 3006425876-2017-00125
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: AU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2018
• Device Catalogue Number: DE-12955-S
• Device Lot Number: 71F16M1326
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/23/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/19/2016
• 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