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

Catalog Number AES-035145

Device Problem Material Separation (1562)

Patient Problem Nonresorbable materials, unretrieved in body (2276)

Event Type  Injury  

Event Description

Customer indicated that the wire came apart inside the patients body and the physician did not realize this until 1 month after the surgery.This was discovered while the patient underwent a ct scan.It was noted that the tip of the wire was still inside the patient's body.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

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

Manufacturer Narrative

The device was not returned to assist in this investigation.The specific procedure it was used during was not disclosed but this wire is sold by urology.It was reported that tip of the wire-guide was discovered during a ct one month after the procedure.The patient did not require any additional procedures due to this occurrence.According to the report, the patient did not experience any adverse effects due to this occurrence.During investigation, a review of complaint history, manufacturing instructions (mi), quality control (qc), specifications and trends was conducted.The wire guide is inspected 100 percent for securement of both distal and proximal weld connections.Length and diameters are inspected with meter scales and ring gages respectively.There are adequate controls in place to ensure the product is produced as intended.Additionally, this type of device failure has generally been associated with the wire guide being damaged by withdrawal and/or manipulated through the needle or other instrument.At this time we are unable to determine with certainty how this incident may have occurred.Our records show this is the first known complaint involving devices for the above described non-conformity, thus equaling an occurrence rate of 0.0015 percent.No additional mitigation activities will be required at this time.The appropriate internal personnel have been notified.We will continue to monitor for similar complaints.

Event Description

Additional information: the patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

• Brand Name: AMPLATZ EXTRA STIFF PTFE FIXED CORE WIRE GUIDE
• Type of Device: ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY, OCY
• Manufacturer (Section D): COOK INC; bloomington IN 47404
• Manufacturer Contact: larry pool, manager ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 4626970
• MDR Text Key: 5592621
• Report Number: 1820334-2015-00156
• 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,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/25/2015

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 Catalogue Number: AES-035145
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Device Age: NA
• Event Location: Hospital
• Initial Date Manufacturer Received: 02/26/2015
• Initial Date FDA Received: 03/19/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/24/2015
• 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