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

Model Number 8830415003

Device Problem Obstruction of Flow (2423)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/08/2018

Event Type  malfunction  

Manufacturer Narrative

Evaluation summary: a device history review revealed no discrepancies that may have contributed to a complaint of this failure mode.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 dhr (device history review) are reviewed for accuracy prior to product release.The physical sample involved in the reported incident was not returned for evaluation.One photo was provided by the customer.Visual evaluation of this photo was performed; the picture show a duals catheter relaxed over one tray together a guide wire; in the image could not see any defect related with the reported condition.In addition, the device showed signs of manipulation (sample outside of the original package and guide rolled outside your its dispenser).The photo provided does not allow determining any related defect with reported condition.This defect has not been confirmed.The product sample was not returned to the manufacturing site for review.Based on the available information, it can be concluded that product was manufactured according to specifications; therefore the most probable cause can be considered as misuse; this defect was more likely patient related condition / catheter placement by the user.No trends or triggers have been found.Therefore, a corrective or preventive action i s not deemed necessary at this time.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.

Event Description

According to the reporter, during insertion of the guide wire through the catheter lumen, it could not pass through both venous and arterial lumens due to some blockage.It was stated that the patient was already on local anesthesia when the issue was found and flushing was not performed prior to insertion.It was also stated that the guide wire was provided with the kit being used however, there was resistance when inserting the guide wire.The procedure was completed with another kit.There was no reported patient injury.

Manufacturer Narrative

Evaluation summary: post market vigilance (pmv) led an evaluation of one device.The visual inspection of the returned product noted no abnormalities.Pmv performed functional testing, the guide wire was inserted and removed and reinserted into the tube without restriction.The catheter was submerged into a water bath.The end was clamped, and a syringe was used to inject air to observe leakage.No air bubbles were present.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.A review of the device history record indicates the product was released meeting all quality release specifications at the time of manufacture.Analysis concluded there were no assembly component related failures.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during insertion of the guide wire through the catheter lumen, it could not pass through both venous and arterial lumens due to some blockage.It was stated that the patient was already on local anesthesia when the issue was found and flushing was not performed prior to insertion.It was also stated that the guide wire was provided with the kit being used however, there was resistance when inserting the guide wire.The doctor tried to insert the guide wire through both the lumens/ports to confirm and when the blockage was confirmed, the procedure was completed with another kit.There was no patient injury.

• 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 st.; mansfield, MA 02048 ; 2034925563
• MDR Report Key: 7667368
• MDR Text Key: 113392646
• Report Number: 3009211636-2018-00229
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 20884521005171
• UDI-Public: 20884521005171
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 09/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2018
• 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 Model Number: 8830415003
• Device Catalogue Number: 8830415003
• Device Lot Number: 331102X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/29/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/30/2016
• 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
• Patient Age: 24 YR