MAUDE Adverse Event Report: COOK INC STRAIGHT FIXED CORE WIRE GUIDE; DQX WIRE, GUIDE, CATHETER

Catalog Number C-SF-15-50

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Pma/510(k) #: pre-amendment.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 the physician was performing a sialoendoscopy using the straight fixed core wire guide.As reported, the wire guide snapped in half inside the patient.They simply pulled it out and another wire guide was used to complete the procedure.No unintended part of the device remained inside the patient¿s body.No additional procedures were required.There were no adverse effects or consequences to the patient resulting from this occurrence.

Event Description

No new information has been obtained since the last report was submitted on 01june2018.

Manufacturer Narrative

Investigation ¿ evaluation: the complaint device was not returned for an evaluation and no photographs were provided.Without the complaint device, a device failure analysis was unable to be performed.A document based investigation was conducted including a review of manufacturing instructions, quality control data, and device specifications.A review of the device history record was unable to be performed as the complaint device lot number was not provided.A review of complaint history records for the complaint device lot could not be performed without knowing the lot number of the complaint device.An analysis of the device was unable to be performed since no product was returned.A similar failure mode for another c-sf-15-50 was addressed under a previous complaint (pr210153).In the previous complaint, the wire guide kinked while inside a scope.During its removal, the wire guide elongated and separated into two separate pieces.However, the wire unraveled into two pieces as opposed to the clean break described in this complaint.It is not clear how exactly this device failed.The customer reported it broke into two pieces which were both pulled out in entirety without additional intervention.This break was noted to be a clean break and in the middle of the wire.It is possible that tortuous patient anatomy contributed to this device failure.Sialendoscopy may be used for salivary gland stone removal, which would mean that calcifications would populate the vessel being navigated.This would help explain the reported clean break in the middle of the wire guide.The patient¿s pre-existing conditions are unknown however so this cannot be confirmed.User technique may have also contributed to the failure.These wire guides are very small (0.015¿ diameter) so it would not take much force for the wire guide to break, especially if calcifications were present on a presumptively smooth vessel.A clean break in the middle of the wire guide has not been observed previously, so previous investigations cannot offer much insight.The device manufacturing record was reviewed and no notable gaps in production or processing controls were noted.These wire guides are 100% inspected for offset, kinked, or outstanding coils so a manufacturing-related cause of failure is unlikely.A definitive conclusion was unable to be made.A clean break in the middle of a wire guide is uncommon, especially in the middle of a small vessel.This failure was noted at the beginning of the procedure, so failure due to other devices can be ruled out.Potentially tortuous anatomy in the form of calcifications may have been present and may have contributed to the failure, but pre-existing patient conditions are not known so this cannot be confirmed.Additionally, since such a small wire guide is being used (0.015¿), the chance of the user accidentally exerting too much force to cause breakage is higher, especially if calcifications were present.The cause of the reported failure mode cannot be established.Per the quality engineering risk assessment, no further action is required.Cook medical has notified the appropriate personnel and will continue to monitor this device via the complaints database for similar complaints.

• Brand Name: STRAIGHT FIXED CORE WIRE GUIDE
• Type of Device: DQX WIRE, GUIDE, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7560878
• MDR Text Key: 109835094
• Report Number: 1820334-2018-01588
• Device Sequence Number: 1
• Product Code: DXQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: C-SF-15-50
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1