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

Catalog Number AUS-038145

Device Problems Unraveled Material (1664); Scratched Material (3020)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/06/2018

Event Type  malfunction  

Manufacturer Narrative

Patient code: no known impact or consequence to patient.Device coded: scratched material, 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 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 event details have been requested; however, 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.

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 four 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 8935584.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 attributed 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.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

There has been no new event information received since the last report was submitted.

Event Description

Report mw5080040 received from fda on 25oct2018.Wire began to unravel as it was being withdrawn intra-operatively.The guide wire remained intact not frayed and did not fragment.The pt was undergoing a cystoscopy with right "retrograde" pyelogram, stent change, left antegrade pyelogram, and nephrostomy change.No harm to pt noted.

• Brand Name: AMPLATZ ULTRA STIFF PTFE FIXED CORE WIRE GUIDE
• Type of Device: OCY ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7902990
• MDR Text Key: 121564821
• Report Number: 1820334-2018-02824
• Device Sequence Number: 1
• Product Code: OCY
• UDI-Device Identifier: 00827002535671
• UDI-Public: (01)00827002535671(17)210628(10)8935584
• Combination Product (y/n): N
• PMA/PMN Number: K082536
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 10/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/28/2021
• Device Catalogue Number: AUS-038145
• Device Lot Number: 8935584
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/15/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 52 YR