MAUDE Adverse Event Report: COOK INC STANDARD FIXED CORE WIRE GUIDE; OCY ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY

Model Number N/A

Device Problem Material Separation (1562)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 02/29/2016

Event Type  Injury  

Manufacturer Narrative

The event is currently under investigation.

Event Description

Per the (b)(4), reported through the fda voluntary event reporting process, the manufacturer was informed that: "the surgeon was attempting to insert a suprapubic catheter.The patient had a very large pannus.The cook needle was passed into the bladder under direct vision.A 0.035 guidewire was placed and gently dilated pt.Up to 14-french.The cope loop nephrostomy tube would not pass and the pt was dilated up to 16-french using the dilator; at which point, the wire was encountered.Multiple attempts were then made to try and get a length of wire that was not kinked and again the surgeon could not pass the cope loop through the belly wall, which was extremely thick.Eventually, in trying to re-dilate him with the stiff dilator, the wire broke.There was nothing visible at the skin; however, there was a piece of wire in the bladder.The surgeon grasped it using the flexible biopsy forceps and was able to unravel some of it, but could not remove the rest of it.At this point, with most of the wire in the bladder, the decision was made to leave the wire.About 2 months ago, the wire was removed as part of a planned evaluation/cystoscopy so did not result in an extra procedure." no additional information was available at the time of this report.

Manufacturer Narrative

Investigation - evaluation: a review of the complaint history, manufacturing investigation, quality control, and specifications was conducted during the investigation.The device was not returned for further investigation.A device history record review could not be performed due to non-availability of device lot number.The investigator was unable to determine if any non-conformances within the manufacturing department were noted.Fracture testing was completed for this device family as part of design verification activities.However, since the device was not returned a device failure analysis could not be completed.Based on the information provided, and the results of the investigation, 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.Per the risk assessment no further action is required.

• Brand Name: STANDARD FIXED CORE WIRE GUIDE
• Type of Device: OCY ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 6178202
• MDR Text Key: 62467062
• Report Number: 1820334-2016-01495
• Device Sequence Number: 1
• Product Code: OCY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082536
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/24/2017

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
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 635413
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/15/2016
• Initial Date FDA Received: 12/15/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/24/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR