MAUDE Adverse Event Report: COSTA RICA PALINDROME HSI 28/45 KIT VT CE; DIALYSIS CATHETER

Model Number 8888145049C

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Fistula (1862)

Event Date 01/08/2016

Event Type  Injury  

Manufacturer Narrative

Submit date: 2/24/2016.An investigation is currently under way; upon completion the results will be forwarded.

Event Description

It was reported to covidien on (b)(6) 2016 that a customer had an issue while using a dialysis catheter which needed to be replaced.The customer reports the palindrome his was inserted on the (b)(6) 2015.They discovered that the catheter had migrated 6-7 cm after dialysis on the (b)(6) 2016, and this was not caused by any specific movements or drag.The catheter is now fixated (is situated in the vena cava), and next week on the (b)(6) 2016 they will decide if they are going to change the catheter or permanently remove it.The patient has a fistula that is maturing.On the (b)(6) 2016, a notification was received that the catheter was removed on the (b)(6) 2016.The catheter was pulled and replaced with a new one.

Manufacturer Narrative

A device history record (dhr) review was performed and no deviations rated to the reported conditions were identified.A sample was returned for evaluation.The sample consisted of a palindrome that came inside a generic plastic bag and the sample presented signs of use; blood residue.Visual inspection was performed and it revealed that the catheter was cut twice in the shaft.The first is a clean cut and is located in the cuff approximately 5 cm below the hub and the second is an irregular cut located approximately 14 cm below the cuff.Additionally, it was observed that the cuff is in the proper position in the shaft and there are no defects within the glue area identified.The catheter was measured in order to verify that the cuff on the shaft of the catheter was in the correct position.The measurement is within specification.As part of the investigation process, the sample was examined and it was observed that the cuff was loose in some areas; however the glue stayed adhered to the catheter.There is evidence of correct glue application per the sample evaluation.Additionally, this sample shows evidence of prolonged usage and cuff wear, therefore it is concluded that this catheter was used and therefore functioned as intended for approximately 2 months.Based on this investigation, the most possible causes are related to misuse (catheter exposed to excessive force, cleaning agents or jerking motion during use).It must be noted that in-process controls (such as personnel training, incoming quality acceptance testing for raw material, 100% in process visual inspection and visual acceptance sampling) are in place to prevent nonconforming product from leaving the manufacturing operations.This complaint will be used for tracking and trending purposes.

• Brand Name: PALINDROME HSI 28/45 KIT VT CE
• Type of Device: DIALYSIS CATHETER
• Manufacturer (Section D): COSTA RICA; covidien manufacturing solulfons sa; edificio 820 calle #2 zona franca coyol; alajuela ; CS
• Manufacturer (Section G): COVIDIEN; covidien manufacturing solulfons sa; edificio 820 calle #2 zona franca coyol; alajuela ; CS
• Manufacturer Contact: thom mcnamara ; 15 hampshire street; mansfield, MA 02048 ; 5084524811
• MDR Report Key: 5457861
• MDR Text Key: 38961555
• Report Number: 3009211636-2016-00090
• Device Sequence Number: 1
• Product Code: MSD
• Combination Product (y/n): N
• Reporter Country Code: NO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 8888145049C
• Device Catalogue Number: 8888145049C
• Device Lot Number: 1504700104
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/12/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 56 YR