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

Model Number	N/A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Device Embedded In Tissue or Plaque (3165)
Date of Event	05/30/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.A follow-up report will be submitted upon receipt of additional information or completion of the investigation.
Event or Problem Description
The customer reported that amplatz ultra stiff ptfe fixed core wire guide malfunctioned during an intended percutaneous nephrolithotomy (pcnl) procedure on a patient.The malfunction was described as the wire separated from the core when removed from the disposable trocar needle.It was further reported that the remaining part of the wire was stuck inside the needle, which was removed with the needle.The disposable trocar needle was disposed off.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.
Additional Manufacturer Narrative
Investigation/evaluation: one used amplatz ultra stiff ptfe fixed core wire guide was returned for investigation.The core is separated from the distal tip weld.The coil is elongated at the distal end.Weld is present on the distal end of the coil.The core wire is 140.4 cm in length.The overall length of the wire guide (with elongated coil) is 220.5 cm.The diameter of the wire guide is.03552 inches.The core wire and diameter measurements are within specification.There is no indication that a design or process related failure mode contributed to this event.A review of the device history record of the finished product shows three non-conformances which were identified and scrapped prior to further processing.A review of complaint history revealed this is the only reported complaint associated to complaint lot number 7447851.Based on the information provided and the results of our investigation; potential root cause is user technique due to removal of the wire guide through the needle.Per the quality engineering risk assessment, no further action is warranted.Monitoring will continue to be performed for similar complaints.Appropriate personnel have been notified of this event.

• Brand Name: AMPLATZ ULTRA STIFF PTFE FIXED CORE WIRE GUIDE
• Common Device Name: OCY ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6669823
• Report Number: 1820334-2017-01523
• Device Sequence Number: 11148125
• Product Code: OCY
• UDI-Device Identifier: 00827002535664
• UDI-Public: (01)00827002535664(17)191203(10)7447851
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K082536
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/20/2017

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
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: AUS-035145
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/30/2017
• Supplement Date Received by Manufacturer: 09/18/2017
• Initial Report FDA Received Date: 06/27/2017
• Supplement Report FDA Received Date: 09/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1