MAUDE Adverse Event Report: COOK INC PERCUTANEOUS NEPHROSTOMY DRAINAGE SET; GBO CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY

Model Number	N/A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Code Available (3191)
Date of Event	05/10/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.
Event or Problem Description
It was reported the guide wire broke inside the patient at the level of the "bell" (bend).The tip fragment was successfully removed.The patient did not require any additional procedures nor experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
(b)(4).Investigation/evaluation a review of complaint history, manufacturing instructions, quality control and a visual inspection and dimensional verification of the returned device were conducted during the investigation.The wire guide was returned in a used and damaged condition.A portion of the distal tip of the wire that separated from the main shaft of the wire guide, measured approximately 2.1 cm in length.Additionally, the safety wire was within the 2.1 cm length segment.It was attached to the distal weld connection.The noted damaged resulted in coil elongation with the safety and mandril wire protrusion.The distal weld connection was intact.There is no evidence to suggest the product was not made to specifications.This device is inspected 100% for bends, kinks, adequate joint strength, correct outside dimension and other surface imperfections prior to transport.It is plausible to suggest that the wire guide met with resistance beyond its intended design during a procedurally related event.Possible inadvertent contact with the bevel of the needle during insertion and/or manipulation of the wire through the needle may have been due to patient anatomy.A definitive root cause could not be determined.We will continue to monitor for similar complaints.Per the quality engineering risk assessment, no further action is required.
Event or Problem Description
It was reported the guide wire broke inside the patient at the level of the "bell" (bend).The tip fragment was successfully removed.

• Brand Name: PERCUTANEOUS NEPHROSTOMY DRAINAGE SET
• Common Device Name: GBO CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 5790087
• Report Number: 1820334-2016-00603
• Device Sequence Number: 1172283
• Product Code: GBO
• UDI-Device Identifier: 00827002034150
• UDI-Public: (01)00827002034150(17)171002(10)5286053
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 06/17/2016

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: PNS-100
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 06/17/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/13/2016
• Supplement Report FDA Received Date: 10/17/2016
• 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