MAUDE Adverse Event Report: COVIDIEN MFG SOLUTIONS S.A. MAHURKAR; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number 8813817009

Device Problem Occlusion Within Device (1423)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/13/2018

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during the procedure, they were unable to insert the guide wire into the catheter because the catheter was blocked.

Manufacturer Narrative

Evaluation summary: a device history record (dhr) review revealed no discrepancies that may have contributed to a complaint of this failure mode.All quality assurance testing performed during manufacturing was acceptable.All dhr are reviewed for accuracy prior to product release.The physical sample involved in the reported incident was not returned for evaluation.Two photos were provided by the customer.Visual evaluation of the photos was performed; the photos show a person introducing a guide wire through catheter, one through the tip and the other through the blue adapter.The evidence does not allow confirmed the reported condition.Based on the available information, the most probable root cause can be considered as customer perception.It must be noted that in-process controls are in place to prevent nonconforming product from leaving the manufacturing operations.This complaint will be used for tracking and trending purposes.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Evaluation summary: a device history review was performed to the reported lot.No discrepancies that may have contributed to a complaint of this nature were found.All dhrs are reviewed for accuracy prior to product release.No changes related to the reported condition were found within six months prior to lots manufacturing date.The physical sample involved in the reported incident was not returned for evaluation.Two photos were provided by the customer.Visual evaluation of the photos was performed; the photos show a person introducing a guidewire through catheter, one through the tip and the other through the blue adapter.The evidence does not allow confirmed the reported condition.The reported condition was not confirmed.It must be noted that in-process controls are in place to prevent nonconforming product from leaving the manufacturing operations.This complaint will be used for tracking and trending purposes.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: MAHURKAR
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101
• Manufacturer (Section G): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101
• Manufacturer Contact: lisa hernandez ; 15 hampshire street; mansfield, MA 02048 ; 2034925563
• MDR Report Key: 7458763
• MDR Text Key: 106619510
• Report Number: 3009211636-2018-00128
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 10884521004917
• UDI-Public: 10884521004917
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K943349
• 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,Followup,Followup
• Report Date: 10/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/03/2021
• Device Model Number: 8813817009
• Device Catalogue Number: 8813817009
• Device Lot Number: 1615300124
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/03/2016
• 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