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 Code	Foreign Body In Patient (2687)
Date of Event	03/17/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.
Event or Problem Description
During a pcnl (percutaneous nephrolithotomy) procedure, it was reported that an amplatz ultra stiff ptfe fixed core wire guide had broken while within the patient.The physician was able to successfully remove the wire guide without difficulty.He then used another wire guide to successfully complete the procedure without any delay.The patient did not require any additional procedures due to this occurrence nor experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
A review of the documents, complaint history, device history record, quality control, and visual inspection was conducted during the investigation of the returned product.One used device was returned for investigation.The wire guide was found elongated.A pull test was performed for breakage at level i inspection.There is no evidence to suggest the product was not manufactured to current specifications.There is no evidence to suggest all items in the lot or similar devices in the field are nonconforming or defective.There is no evidence the product was damaged upon opening.Review of device history record shows no nonconforming events which could contribute to this failure mode.Instruction for use (ifu) states, ¿use caution not to force or over manipulate the wire guide when gaining access.¿ there is no information regarding any patient anatomical characteristics that may have led to a broken wire guide.There is no information regarding any angulation required or any resistance encountered during the procedure.Based upon the information provided and the characteristics displayed, root cause cannot be definitively confirmed.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: 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: 6452982
• Report Number: 1820334-2017-00631
• Device Sequence Number: 19176976
• Product Code: OCY
• UDI-Device Identifier: 00827002535671
• UDI-Public: (01)00827002535671(17)190801(10)7116757
• Combination Product (Y/N): N
• PMA/510(K) Number: K082536
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/24/2017

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: AUS-038145
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/17/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/03/2017
• Supplement Report FDA Received Date: 05/24/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention