MAUDE Adverse Event Report: COVIDIEN MFG SOLUTIONS S.A. MAHURKAR ELITE; CATHETER, HEMODIALYSIS, NON-IMPLANTED

Model Number 8888211316

Device Problems Break (1069); Kinked (1339)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The incident sample has been requested but to date has not been received for evaluation.If the sample is received or if additional information pertinent to the incident is obtained a follow-up report will be submitted.

Event Description

The customer states during ultrasound guided insertion, the guide wire passed through the needle and the two dilators passed over the guide wire well.When the catheter was passed over the guide wire and the proximal end of the guide wire exited the venous port it was frayed.The guide wire and catheter were removed from the patient and another catheter was inserted with no problems.Anecdotally, the doctor also commented that approximately 6 months ago he had heard that another resident had the distal end of the guide wire fray during the insertion of a triple lumen catheter being inserted in the icu.He had no other details regarding that incident.

Manufacturer Narrative

This report was filed in error as a broken guidewire.This event should not have been reported.Investigation summary: a device history record (dhr) review was performed and no discrepancies that may have contributed to a complaint of this failure mode were identified.All quality assurance testing performed during manufacturing was acceptable.The quality assurance review of the visual, physical and dimensional evaluation results indicated that the product met specification requirements.In addition, all dhrs are reviewed for accuracy prior to product release.The sample was received for evaluation.One guidewire and catheter were returned along with the original package.The guidewire was found stretched and kinked in different locations and the guidewire coil area was frayed.The guidewire was able to pass through both lumens of the catheter and dimensional testing showed no issues.An ishikawa diagram was used to determine the potential causes for this event.Based on sample evaluation the reported condition was confirmed but the failure cannot be attributed to manufacturing.All gathered information shows that the most probable root cause for this event is incorrect technique.The sample received from the customer was stretch and kinked which can be produced by incorrect technique.The instructions for use (ifu) state to not insert or withdraw the guidewire forcibly from any component, the guide wire could break or unravel.No trends were identified related to the failure mode; no actions are required based on the investigation findings.It must be noted that controls are in place to prevent nonconforming product from leaving the manufacturing process.This complaint will be used for tracking and trending purposes.If information is provided in the future, a supplemental report will be issued.

• Brand Name: MAHURKAR ELITE
• Type of Device: CATHETER, HEMODIALYSIS, NON-IMPLANTED
• Manufacturer (Section D): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 0101
• Manufacturer (Section G): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 0101
• Manufacturer Contact: diane matheus ; 15 hampshire street; mansfield, MA 02048 ; 5085421480
• MDR Report Key: 6851657
• MDR Text Key: 85306442
• Report Number: 3009211636-2017-05288
• Device Sequence Number: 1
• Product Code: MPB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/30/2018
• Device Model Number: 8888211316
• Device Catalogue Number: 8888211316
• Device Lot Number: 1613900266
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/01/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/20/2016
• 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