MAUDE Adverse Event Report: COOK INC AMPLATZ EXTRA STIFF PTFE DOUBLE FLEXIBLE WIRE GUIDE; OCY ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY

Model Number N/A

Device Problem Material Disintegration (1177)

Patient Problem Foreign Body In Patient (2687)

Event Type  Injury  

Manufacturer Narrative

(b)(4).The event is currently under investigation.

Event Description

Upon completion of a cystogram with a diagnostic ureteroscopy case, the user noted blue coating coming off on their hands and inside of the patient.It is unknown if or how the coating was addressed with the patient.Additional information has been requested, however it was not provided at the time of this report.

Manufacturer Narrative

(b)(4).Event evaluation: a review of complaint history, instructions for use (ifu), manufacturing instructions, quality control and specifications was conducted during the investigation.The device was not returned to assist in the investigation.There is no evidence to suggest all items in the lot or similar devices in house are nonconforming or defective.Without more specific details of the event, it is not possible to determine root cause of the separation in this case.There is insufficient risk due in part to high detection activities, low occurrence and low severity to warrant risk reduction activities.Key internal personnel have been notified and we will continue to monitor for similar events.

Event Description

Upon completion of a cystogram with a diagnostic ureteroscopy case, the user noted blue coating coming off on their hands and inside of the patient.It is unknown if or how the coating was addressed with the patient.No additional information has been provided regarding patient outcome.

• Brand Name: AMPLATZ EXTRA STIFF PTFE DOUBLE FLEXIBLE 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: 5125053
• MDR Text Key: 27412867
• Report Number: 1820334-2015-00601
• 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: company representative
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 09/10/2015

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: AES-038145-DF
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Device Age: 1 MO
• Event Location: Hospital
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/02/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/20/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/04/2015
• 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