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

Catalog Number	AUS-038145
Medical Device Problem Codes	Peeled/Delaminated (1454); Unraveled Material (1664)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/06/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient code: no known impact or consequence to patient.Device coded: peeled, coil, unraveled is not labeled.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.
Event or Problem Description
It was reported while using the amplatz ultra stiff ptfe fixed core wire guide, the coating is scratched off and now the outer coil is unraveling.Also, the inner part of the wire is poking out.Another device (unknown make and manufacturer) was opened and used to complete the procedure.As reported, there was no unintended part of the device left in the patient's body.No additional procedures were required and there were no adverse consequences to the patient as a result of this reported event.Additional information has been requested about this event.No information has been forthcoming at the time of this report.The instructions for use (ifu) that accompanies this device provides the following precaution: when using wire guide through a metal cannula/needle, use caution as damage may occur to outer coating.The ifu's how supplied section also instructs: upon removal from package, inspect the product to ensure no damage has occurred.
Event or Problem Description
There has been no new information received since the last report was submitted.
Additional Manufacturer Narrative
Investigation ¿ evaluation: the complaint device was not returned for an evaluation and no photograph or imaging was provided.Without the complaint device, a device failure analysis was unable to be performed.A document based investigation was conducted including a review of complaint history, the device history record, instructions for use, manufacturing instructions, quality control data, and specifications.A review of the device history observed non-conformances related to the reported failure mode.However, all relevant nonconforming devices were scrapped, and all remaining devices in the lot underwent quality control activities such as tensile tests, surface damage checks, and outer diameter gaging.Since these 100% inspection procedures are in place and no other complaints have originated from this lot, no nonconforming devices are suspected in house or in the field.A review of complaint history records revealed no other complaints associated with the complaint device lot number 9005857.This device is shipped with the instructions for use (ifu) which contains the following relevant precaution: manipulation of the wire guide requires appropriate imaging control.Use caution not to force or over manipulate the wire guide when gaining access.The device manufacturing record showed no gaps in production or processing controls.Sufficient controls are in place to detect this failure mode prior to release.There is not enough information regarding the procedure, the patient, and the equipment to isolate a main cause of failure.Unraveling of wire guides is commonly observed when a wire guide is withdrawn through a metal needle/cannula, as is cautioned against in the instructions for use (ifu), but the customer did not report use of any needle or device with a metal cannula.Potentially tortuous anatomy may have contributed to the event, but no information was provided about patient anatomy.Considering the quality control procedures in place, a manufacturing cause of failure is not suspected.A definitive conclusion regarding the main cause of failure could not be made.Per the quality engineering risk assessment, no additional risk mitigating activity is required at this time.Cook medical has notified the appropriate personnel and will continue to monitor this device via the complaints database for similar complaints.

• 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: 7902937
• Report Number: 1820334-2018-02823
• Device Sequence Number: 1552377
• Product Code: OCY
• UDI-Device Identifier: 00827002535671
• UDI-Public: (01)00827002535671(17)210730(10)9005857
• Combination Product (Y/N): N
• Initial Reporter State: RI
• 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,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/27/2018

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 Expiration Date: 07/30/2021
• Device Catalogue Number: AUS-038145
• Device Lot Number: 9005857
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/10/2018
• Supplement Date Received by Manufacturer: 11/15/2018
• Initial Report FDA Received Date: 09/24/2018
• Supplement Report FDA Received Date: 11/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 49 YR