MAUDE Adverse Event Report: COOK INC ENDOSCOPIC CHOLANGIOGRAPHY SET; GBZ CATHETER, CHOLANGIOGRAPHY

Model Number	N/A
Medical Device Problem Codes	Material Separation (1562); Sticking (1597); Structural Problem (2506); Physical Resistance (2578)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/07/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.A follow-up report will be submitted upon receipt of additional information or completion of the investigation.
Event or Problem Description
International customer reported that a cook endoscopic cholangiography set was provided to a surgeon for trial.The surgeon commented that the 5 fr catheter was a tight fit into the needle.The surgeon completed the procedure without any incidents or complications.There are no reported adverse patient consequences.The surgeon then opined that there exists a strong risk that the distal end of the catheter could be cut or sliced off by the needle when the catheter is extracted after it was fully engaged and passed the distal end of the needle.The surgeon demonstrated this concern to the sales representative.There was no patient involvement at the time of this demonstration, accordingly there is no reported adverse patient consequence associated with this potential malfunction.The device is reportedly available for examination.The device has not been received as of the date of this report.
Additional Manufacturer Narrative
A review of the documentation, dimensional verification, functional testing, device history record, drawing, manufacturing instructions, specification and quality control data was conducted during the investigation.The device history record for lot number 7465744 was reviewed and noted no non-conformances in the manufacturing department.The device history records for the component lots ic7375653 and ic7375663 were reviewed and no non-conformances were noted.A complaint history search revealed this complaint to be the only reported complaint associated to the complaint lot number.One used product was returned for further investigation.A device failure analysis was performed on the returned device.Dimensional and functional verification tests were performed.The top down projection of the bevel and catheter outer diameter were measured and both fell within the manufacturing specifications.Since the failure mode pertained to the catheter passing through the needle, the inner diameter was measured.A 0.068¿ gauge pin was able to pass through the inner diameter of the needle at the end hole.The catheter outer diameter was 0.067¿, less than the measured inner diameter of the needle.It was noted that significant resistance was encountered when advancing the catheter through the inner diameter of the needle.Once the catheter reached the needle bevel, it could not advance any more.For the needle to slice the end of the catheter off, a very ¿abrupt tug¿ would be needed to slice the catheter off since the beveled end of the needle is dulled during the manufacturing process.This ¿abrupt tug¿ could have come from the fact that the interface between the catheter and needle was not smooth.Since the surface finish and inner diameter inside the needle could not be checked, the root cause may have been due to the surface finish on the inner diameter of the needle, i.E.Manufacturing related.We will notify the appropriate personnel and continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.

• Brand Name: ENDOSCOPIC CHOLANGIOGRAPHY SET
• Common Device Name: GBZ CATHETER, CHOLANGIOGRAPHY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6463419
• Report Number: 1820334-2017-00599
• Device Sequence Number: 18951782
• Product Code: GBZ
• UDI-Device Identifier: 00827002031968
• UDI-Public: (01)00827002031968(17)191122(10)7465744
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: ECS-500-TUOHY
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/07/2017
• Supplement Date Received by Manufacturer: 09/15/2017
• Initial Report FDA Received Date: 04/06/2017
• Supplement Report FDA Received Date: 10/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1