MAUDE Adverse Event Report: COOK INC STRANGE CHOLANGIOGRAPHY SET; LQR DISLODGER, STONE BILIARY

Model Number	N/A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	03/01/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient age at time of event was not provided.Patient sex at time of event was not provided.It is unknown if the initial reporter is a health professional.(b)(4).This event is currently under investigation.
Event or Problem Description
During a common bile duct expiration procedure, the first gallstone that the surgeon retrieved came easily.The surgeon then re-advanced the basket through the catheter with the graspers and he thinks he may have kinked the wire with his graspers.When he captured the second stone with the basket, he felt some resistance and pulled to retrieve the stone when the basket broke.An incision was made through the common duct and the basket was removed.
Additional Manufacturer Narrative
(b)(4).Investigation - evaluation a review of the complaint history, manufacturing instructions, specifications, trends and quality control was conducted during the investigation.The complaint description identified that potentially the root cause was the use of grasper to advance the basket had resulted in a kink."then re-advanced the basket through the catheter with the graspers and he thinks he may have kinked the wire with his graspers".The complaint also specified the device worked once.Indicating that for part of the procedure the device was functional.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.It should be noted there were no other reported complaints for this lot number.Review of production documentation, did not observe any specific issues with current manufacturing controls that may have contributed to this incident.In addition, review of device master record did not observe any non-conformances that may have contributed to this incident.Based upon the available information, user technique may have contributed to this incident, however a definitive root cause cannot be determined.The appropriate internal personnel have been notified and we will continue to monitor for similar complaints.Per the risk assessment, no further action is required.
Event or Problem Description
During a common bile duct expiration procedure, the first gallstone that the surgeon retrieved came easily.The surgeon then re-advanced the basket through the catheter with the graspers and he thinks he may have kinked the wire with his graspers.When he captured the second stone with the basket, he felt some resistance and pulled to retrieve the stone when the basket broke.An incision was made through the common duct and the basket was removed.

• Brand Name: STRANGE CHOLANGIOGRAPHY SET
• Common Device Name: LQR DISLODGER, STONE BILIARY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 5641412
• Report Number: 1820334-2016-00312
• Device Sequence Number: 10774529
• Product Code: LQR
• UDI-Device Identifier: 00827002091085
• UDI-Public: (01)00827002091085(17)180809(10)6474447
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: C-CSRC-7.5D-40-STRANGE
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/01/2016
• Device Age: 4 MO
• Event Location: Hospital
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/04/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/09/2016
• Supplement Report FDA Received Date: 09/15/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention