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

Model Number	N/A
Medical Device Problem Codes	Crack (1135); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/22/2017
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
The international customer reported that, when the device was removed from the packaging and saline was injected into the saline port for the first time, a leak was observed.The source was reportedly a crack in the 3 way tap of the device.A second device was opened to continue the procedure with no further complications reported.The customer confirmed that there were no adverse patient outcomes.The device is reportedly unavailable for return.
Additional Manufacturer Narrative
Pma/510(k) #:exempt: investigation ¿ evaluation: a review of the complaint history, device history record, documentation, drawing, instructions for use (ifu), manufacturing instructions, quality control, and specifications of the device was conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.A review of the device history record shows no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.Based on the information provided, no product returned and the results of our investigation, a definitive root cause could not be determined.The proper personnel have been noted of this event and we will continue to monitor similar complaints.Per the quality engineering risk assessment no further action is required.
Event or Problem Description
The international customer reported that, when the device was removed from the packaging and saline was injected into the saline port for the first time, a leak was observed.The source was reportedly a crack in the 3 way tap of the device.A second device was opened to continue the procedure with no further complications reported.The customer confirmed that there were no adverse patient outcomes.The device is reportedly unavailable for return.Additional information received identified the event occurred during a common bile duct exploration during cholecystectomy.Photos, operating reports, x-rays, and scans were requested.The reporter indicated that such will not be provided.

• Brand Name: FANELLI CHOLANGIOGRAPHY CATHETER SET
• Common Device Name: GBZ CATHETER, CHOLANGIOGRAPHY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6914644
• Report Number: 1820334-2017-03443
• Device Sequence Number: 1312734
• Product Code: GBZ
• UDI-Device Identifier: 00827002129504
• UDI-Public: (01)00827002129504(17)200619(10)8001002
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/05/2018

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: C-FCC-100
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/22/2017
• Supplement Date Received by Manufacturer: 03/13/2018
• Initial Report FDA Received Date: 10/04/2017
• Supplement Report FDA Received Date: 04/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1