MAUDE Adverse Event Report: CONSOLIDATED MEDICAL EQUIPMENT COMPANY MARKED GUIDEWIRE; AMERICAN DILATION SYSTEM

Catalog Number 000150

Device Problem Bent (1059)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/16/2018

Event Type  malfunction  

Manufacturer Narrative

The reported device is expected to be returned for evaluation.A supplemental and final report will be filed upon completion of the product evaluation and complaint investigation.

Event Description

The user facility reported that when the 000150 guidewire was removed during a procedure, it was noticed to be bent.The procedure was completed with no surgical delays or patient injury.Although multiple attempts have been made, no additional information regarding patient status or procedure has been provided.This report is being raised on the basis of a reported malfunction with potential for injury with recurrence.

Manufacturer Narrative

Although multiple attempts were made to gather additional information and for the return status of the reported device to conmed, neither has been provided by the facility; therefore, the reported failure could not be verified and a root cause cannot be conclusively determined.A review of the manufacturing documents verified the device was produced per current and approved procedures and material specifications.Non-conformances regarding the product's identity, quality, safety, effectiveness or performance were not identified at the time of manufacture.A review of this lot number showed no other complaint for this lot product, with 138 pieces manufactured, and event description.A two-year review of complaint history revealed 9 other similar complaints for this product family and failure mode.In that same timeframe, (b)(4) units of this product family have been sold worldwide, making the rate of occurrence of this failure 0.042 percent, if all complaints were confirmed.The instructions for use advises the user of the following.The guidewire should not be advanced if resistance is met without determining the cause and taking remedial action.Inspect the flexible spring tip and discard the wire if the tip appears to be bent or fatigued.Also inspect the soldered joints and discard the wire of the soldered joints appear discolored, lose or cracked.This issue will continue to be monitored through the complaint system to assure patient safety.

Manufacturer Narrative

Corrected data: (b)(4).Manufacturer narrative: the used device was returned to conmed for evaluation with opened original packaging.The reported catalog and lot numbers were verified.Visual inspection found a kink in the spring tip, and the spring began to un-coil near the kinked area.

• Brand Name: MARKED GUIDEWIRE
• Type of Device: AMERICAN DILATION SYSTEM
• Manufacturer (Section D): CONSOLIDATED MEDICAL EQUIPMENT COMPANY; ave. alejandro dumas no. 11321; complejo industrial chihuahua; chihuahua CP 11 36; MX CP 1136
• MDR Report Key: 7510676
• MDR Text Key: 108150497
• Report Number: 3007305485-2018-00100
• Device Sequence Number: 1
• Product Code: KNQ
• Combination Product (y/n): N
• PMA/PMN Number: K853274
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 07/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2018
• Device Catalogue Number: 000150
• Device Lot Number: 201803014
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1