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 Flaked (1246)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The user states that they have been experiencing flaking of the coating on the wire guide regularly.No additional information has been provided.According to the initial reporter, the patient did not require any additional procedures nor experience any adverse effects due to this occurrence.

Manufacturer Narrative

(b)(4).Event evaluation: a review of complaint history and specifications was conducted during the investigation.No product was returned to assist in the investigation.There is no evidence to suggest that there is additional nonconforming/defective product.Without more specific details of the event, it is not possible to determine root cause of the separation in this case.Key internal personnel have been notified and will continue to monitor for similar events.There is insufficient risk due in part to high detection activities, low occurrence and low severity to warrant risk reduction activities.

Event Description

The user states that they have been experiencing flaking of the coating on the wire guide regularly.No additional information has been provided.According to the initial reporter, the patient did not require any additional procedures nor experience any adverse effects due to this occurrence.

• 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: 5085957
• MDR Text Key: 26116002
• Report Number: 1820334-2015-00597
• 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: 08/24/2015

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
• 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
• Event Location: Hospital
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/17/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/17/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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