MAUDE Adverse Event Report: COOK INC FANELLI LAPAROSCOPIC ENDOBILIARY STENT SET; FGE CATHETER, BILIARY, DIAGNOSTIC

Model Number	N/A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/02/2017
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 the device was being examined prior to use.A piece of loose plastic was observed in the package during this examination.The customer indicated that the device fractured 2cm from the tip.The package with device was not used and exchanged for another device.There was no patient contact.The device is available for examination, however it has not been received by the manufacturer as of the date of this report.
Additional Manufacturer Narrative
A review of device history record, documentation, manufacturing instructions, visual inspection, instructions for use (ifu), specification and quality control data was conducted during the investigation.A review of production and quality documentation did not observe any specific issues with current manufacturing or quality controls that may have contributed to this incident.A review device history record revealed one nonconformance, a documentation error, which was not determined to be related to the device failure mode.Visual examination of the returned device confirmed the report.The white stent on the distal end of the guiding catheter was found cracked and broken.The stent material was hard and brittle as if it has been prematurely aged.A normal stent should be soft and pliable.The distal portion of the stent from the flap down was found missing.There is also clear liquid inside the guiding catheter.A discrepancy or anomaly that could have contributed to the reported observation was not observed during our laboratory analysis of the returned product.Although the ifu instructs, ¿store in a dark, dry, cool place.Avoid extended exposure to light," it is plausible to suggest that the device or the raw material tubing was stored in a lit area, leading to premature aging of the material.We will notify the appropriate personnel and continue to monitor for similar complaints.Measures have been previously initiated to address this issue.Per the quality engineering risk assessment no further action is required.

• Brand Name: FANELLI LAPAROSCOPIC ENDOBILIARY STENT SET
• Common Device Name: FGE CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6582348
• Report Number: 1820334-2017-01012
• Device Sequence Number: 1266928
• Product Code: FGE
• UDI-Device Identifier: 00827002136991
• UDI-Public: (01)00827002136991(17)180301(10)5754074
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K010601
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/12/2017

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: C-FBSS-100
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/02/2017
• Supplement Date Received by Manufacturer: 09/27/2017
• Initial Report FDA Received Date: 05/22/2017
• Supplement Report FDA Received Date: 10/12/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1