MAUDE Adverse Event Report: COVIDIEN KIT 11.5FX19.5CM MAHURKAR; DIALYSIS CATHETER

Model Number 8813793009

Device Problems Difficult to Remove (1528); Sticking (1597); Device Or Device Fragments Location Unknown (2590)

Patient Problem No Information (3190)

Event Date 01/20/2016

Event Type  malfunction  

Manufacturer Narrative

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 with a dialysis catheter.The customer reports after the placement of the catheter at the left femoral vein; the doctor tried to remove the guide wire out of the catheter but he found that the guide wire got stuck inside so he cannot remove it out of the patients body.The patient was sent for a contrast media injection to find the position of the catheter and consult cvt surgeon for surgery to remove the catheter and guide wire.Surgery time was extended by more than 30 minutes.The product was tested prior to use.

Manufacturer Narrative

Additional information was provided on (b)(6) 2016.The patient is stable.The contrast media injection was performed to confirm the foreign body in the vessel and location in the vein.The guidewire/catheter was removed on (b)(6) 2016 surgically.There was not thought to be any abnormal patient anatomy at the time of insertion or removal.

Manufacturer Narrative

The complaint sample was not returned to the manufacturing site for review.The device history record (dhr) review indicated that there was no quality issues associated with this failure.All dhrs are reviewed for accuracy prior to product release.Since the sample was not returned, there is not enough evidence to determine what could cause this event.Should the sample be returned in the future, this complaint will be re-opened for further investigation.It must be noted that in-process controls (such as personnel training, incoming quality acceptance testing for raw material, in process visual inspection and visual acceptance sampling) in place to prevent nonconforming product from leaving the manufacturing operations.This complaint will be used for tracking and trending purposes.

• Brand Name: KIT 11.5FX19.5CM MAHURKAR
• Type of Device: DIALYSIS CATHETER
• Manufacturer (Section D): COVIDIEN; 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: 5387697
• MDR Text Key: 36929097
• Report Number: 3009211636-2016-00053
• Device Sequence Number: 1
• Product Code: MSD
• Combination Product (y/n): N
• Reporter Country Code: TH
• 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,Followup
• Report Date: 01/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8813793009
• Device Catalogue Number: 8813793009
• Device Lot Number: 1507500122
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/19/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR
• Patient Weight: 54