MAUDE Adverse Event Report: CONSOLIDATED MEDICAL EQUIPMENT COMPANY MARKED GUIDEWIRE (2/CS); DILATOR, ESOPHAGEAL

Model Number 000150

Device Problem Material Fragmentation (1261)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/21/2021

Event Type  malfunction  

Manufacturer Narrative

Investigation of the event is confirmed.Conmed received one 000150 returned opened in unoriginal packaging.The lot number of the device could not verified be verified.A visual inspection found the spring was bent/kinked on one end & detached from the marked guidewire.The spring detached from the marked guidewire at the end where the guidewire is soldered into the end cap with hole.The portion of the spring that was kinked is the end with hole in which the spring and guidewire are soldered.The device history record manufacturing records have been reviewed & found no abnormalities that would contribute to this issue.(b)(4).Instructions for use (ifu) provide the user information regarding proper care & use of this device.The ifu also advises that the guidewire should be not advanced if resistance is met without determining the cause & taking remedial action.Before & after each use, carefully inspect the guidewire for wear, damage or abnormal bending.The entire wire should be inspected in this manner, but areas of extra focus include the flexible spring tip & the soldered joints between the spring tip & the wire.If the joints appear discolored, loose or cracked, discard the guidewire.If wear, damage or abnormal bending is found at any location on the guidewire discard the guidewire.This issue will continue to be monitored through the complaint system to assure patient safety.

Event Description

On behalf of the facility, the conmed representative reported issues with the 000150, spring tip marked guidewire, lot 202101134, that digestive endoscopy center recently experienced on (b)(6) 2021.The information received that after savory dilation, the spring broke loose from the guide wire and fell into the gastric pouch.Spring was retrieved using a snare resulting in no complications.It was the first time use of the guide wire.It is noted there was no impact or injury to the patient and the procedure was successfully completed.Additional information received indicates an esophageal dilation was being performed when the spring broke from the guidewire.This was the first time the facility opened the package and used the product.It is unknown what dilator was being utilized in this procedure.There was nothing unusual or concerning about the spring tip guidewire prior to its use.Additional information received via sus voluntary event report # mw5101802.It is noted the event was (b)(6) (not (b)(6)).The doctor was using the 000150, when removed, staff noticed the tip had broken off in the patient.Another scope was inserted and the foreign body was removed.Communication with the reporter confirmed the incident was on the (b)(6) not the (b)(6) 2021.Also, they inserted another guidewire not a completely different scope.There was no surgical intervention other than them removing the broken piece.This incident is being reported on the basis of malfunction with potential for injury upon reoccurrence as the fragment was removed.

• Brand Name: MARKED GUIDEWIRE (2/CS)
• Type of Device: DILATOR, ESOPHAGEAL
• Manufacturer (Section D): CONSOLIDATED MEDICAL EQUIPMENT COMPANY; ave. alejandro dumas 11321; complejo industrial chihuahua; chihuahua 31136 ; MX 31136
• MDR Report Key: 12411164
• MDR Text Key: 280774461
• Report Number: 3007305485-2021-00365
• Device Sequence Number: 1
• Product Code: KNQ
• UDI-Device Identifier: 10653405050858
• UDI-Public: (01)10653405050858(11)210113(10)202101134
• Combination Product (y/n): N
• PMA/PMN Number: K853274
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial
• Report Date: 09/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 000150
• Device Catalogue Number: 000150
• Device Lot Number: 202101134
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2021
• Date Manufacturer Received: 05/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1