MAUDE Adverse Event Report: COVIDIEN TROCAR CATH 8FR; TROCAR CATHETER

Model Number 8888560805

Device Problems Break (1069); Material Puncture/Hole (1504); Difficult to Remove (1528)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 02/19/2015

Event Type  Injury  

Event Description

It was reported to covidien on (b)(6) 2015 that a customer had an issue with a trocar catheter.The customer reports that during the procedure it punctured within the child's chest, the rounded grip of the trocar was crushed and it was impossible to remove the trocar.The second one opened by the customer was stuck to the container and the catheter was stuck and it was possible to remove the trocar only.The customer further reports no patient injury.

Manufacturer Narrative

(b)(4).An investigation is currently underway.Upon completion, the results will be forwarded.

Manufacturer Narrative

One open sample was returned to the manufacturing facility.Visual examination finds that the catheter and rod and ball were fully intact and that there was no evidence of crushing.The complaint indicates that there are two issues, one where the ball was crushed and one where the catheter was stuck to the container.The root cause of the ball being crushed cannot be determined as the ball is intact on the returned sample.During manufacturing of the rod and ball assembly each unit is pull tested.The returned sample was pull tested and passed the pull test.The unit returned may be the unit from the second issue where the catheter was stuck to the container.Based on the additional notes received with this complaint it appears that when removing the trocar from the catheter , the rod of trocar crushed.By this we interpret the ball disconnected from the rod.A failure inspection has been completed and the most probable root cause was determined to be process related.A number of process improvements were introduced to improve process capability.Additionally a new in-process torque test was introduced to replicate the twisting/rotating motion when the clinician removes the trocar rod.The returned sample was removed from the container so the reported condition cannot be confirmed if the catheter was stuck to the escon tube.A review of the manufacturing process was carried out and documented.It identifies that near the end of the process the catheter is dipped in cyclohexanone to ensure the tip is smooth.A possible root cause is that if there is too much cyclohexanone on the tip of the catheter that the unit may stick to the escon tube.A quality alert was issued to the manufacturing team to ensure there is no excess cyclohexanone on the catheter.At present the method for applying cyclohexanone is being reviewed and the manufacturing work instruction is being updated to include a quality note to check for excess cyclohexanone.The device history record (dhr) review showed that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process of lot 14g446fhx.Based on the above no further action is required at this time.This complaint will also be used for trending and tracking purposes.

• Brand Name: TROCAR CATH 8FR
• Type of Device: TROCAR CATHETER
• Manufacturer (Section D): COVIDIEN; sragh industrial estate; county offaly; tullamore
• Manufacturer (Section G): COVIDIEN; sragh industrial estate; county offaly; tullamore ; EI
• Manufacturer Contact: thom mcnamara ; 15 hampshire street; mansfield, MA 02048 ; 5084524811
• MDR Report Key: 4565208
• MDR Text Key: 18898732
• Report Number: 9612030-2015-00015
• Device Sequence Number: 1
• Product Code: DRC
• Combination Product (y/n): N
• Reporter Country Code: PL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8888560805
• Device Catalogue Number: 8888560805
• Device Lot Number: 14G446FHX
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/27/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1