MAUDE Adverse Event Report: COOK INC MANASHIL SIALOGRAPHY CATHETER

Model Number	N/A
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/24/2017
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 reports that a patient was undergoing a sialography.A leak was noted in the manashil sialography catheter.A replacement device was obtained to complete the procedure.There are no reported adverse patient consequences associated with this event.
Additional Manufacturer Narrative
Investigation ¿ evaluation: a review of the complaint history, device history record, drawing, manufacturing instructions, quality control, and a visual inspection of the returned device were conducted during the investigation, and no issues were found related to the reported issue.The visual inspection of the returned wire confirmed that the flare was within specifications, and no damage to the cap thread connection was noted.A leak test showed leakage at the threads where they connect to the syringe, although no damage was noted on the threads.In addition, the id of the end hole accepts a 0.042" pin gage, which is within manufacturing specifications.The diameter of the shaft flare is 0.150" which is also within manufacturing specification of 1.109" to 0.152".While the adequacy of the glue bond cannot be definitively determined from the used device, the flare was within specifications and no damage to the cap thread connection was noted.Additionally, 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 showed 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, the examination of the returned product, and the results of our investigation, a definitive root cause could not be determined.Per the quality engineering risk assessment, no further action is required.Cook medical has notified the appropriate personnel and will continue to monitor this device via the complaints database for similar complaints.

• Brand Name: MANASHIL SIALOGRAPHY CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6665799
• Report Number: 1820334-2017-01491
• Device Sequence Number: 999288
• Product Code: GCB
• UDI-Device Identifier: 00827002011144
• UDI-Public: (01)00827002011144(17)200116(10)7594713
• Combination Product (Y/N): N
• Initial Reporter Country: ZA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/22/2018

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: SCSM-P-12
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/29/2017
• Supplement Date Received by Manufacturer: 01/10/2018
• Initial Report FDA Received Date: 06/23/2017
• Supplement Report FDA Received Date: 01/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 43 YR