MAUDE Adverse Event Report: COOK INC AMPLATZ EXTRA 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)
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 extra stiff ptfe fixed core wire guide malfunctioned during an intended percutaneous nephrolithotomy (pcnl) procedure on a patient.The malfunction was described as the teflon coating of the wire guide came off inside the patient¿s body.No unintended section of the device remained inside the patient¿s body.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
A review of the complaint history, device history record, documentation, instructions for use (ifu), manufacturing instructions, specifications, trends, quality control, and visual inspection of the returned device was conducted during the investigation.One used and one unused amplatz extra stiff ptfe fixed core wire guides were returned for investigation.Both devices were within specification for diameter and length.The unused wire guide presented no nonconformities.The used wire guide presented with nonconformities: missing coating measuring from the proximal end at 3.9cm and 1 mm in length, 5.2cm and 1mm in length, 10.2cm and 1mm in length, 10.5cm and 2mm in length, 116.2cm and 6mm in length, 117.4cm and 1mm in length, 118.0cm and 1mm in length, 123.0cm and 6mm in length, 124.0 cm and 22.3 cm in length (the remaining distal end).A bend is noted at 139.5 cm from the proximal end.A document based investigation evaluation was also performed.There is no evidence to suggest the product was not made to specifications.Review of the device history record of the finished product shows four nonconforming events related to this failure mode.There were no other reported complaints for this lot number.The device is shipped with an instruction for use (ifu) that state: precautions- ''when using wire guide through a metal cannula/needle, use caution as damage may occur to outer coating.'' based on the information provided and the results of our investigation, a definitive root cause could not be determined.Per the quality engineering risk assessment, no further action is warranted.Monitoring will continue to be performed for similar complaints.
Event or Problem Description
The customer reported that amplatz extra stiff ptfe fixed core wire guide malfunctioned during an intended percutaneous nephrolithotomy (pcnl) procedure on a patient.The malfunction was described as the teflon coating of the wire guide came off inside the patient¿s body.An unintended section of the device remained inside the patient¿s body.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
• Common Device Name: OCY ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6557176
• Report Number: 1820334-2017-00844
• Device Sequence Number: 13473573
• Product Code: OCY
• UDI-Device Identifier: 00827002535602
• UDI-Public: (01)00827002535602(17)190429(10)6876822
• 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,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2017

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: AES-038145
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/18/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/10/2017
• Supplement Report FDA Received Date: 06/24/2017
• 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: Other