MAUDE Adverse Event Report: CONSOLIDATED MEDICAL EQUIPMENT SPRING TIP MARKED GUIDEWIRE; DILATOR, ESOPHAGEAL

Catalog Number 000150

Device Problem Material Fragmentation (1261)

Patient Problem Gastrointestinal Hemorrhage (4476)

Event Date 03/02/2021

Event Type  Injury  

Manufacturer Narrative

At time of filing, the reported device has not been, and is not expected to be, returned to conmed for evaluation.This reported event is entering the investigation process.A supplemental and final report will be filed following the completion of the complaint investigation.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 unknown, that (b)(6) medical center recently experienced on (b)(6) 2021.The only information received was that the spring tip of guidewire broke off and caused bleeding in the patient.Patient had to be admitted and received 3 dc0235w clips to control bleeding.To date, although multiple attempts have been made to gather additional information, no response has been received and no clarification has been made available.This report is being raised on the basis of injury as it is reported the device caused bleeding that required re-admission to the health facility.

Event Description

Additional information received indicates the procedure was an endoscopic procedure to dilate an esophageal stricture.During the usage, the tip of the guidewire broke off.There was post op bleeding in the stomach and the patient was admitted to the hospital.The bleeding was controlled by the use of 3 hemostasis clips.No other information is known.

Manufacturer Narrative

Investigation of the customer's complaint of breakage is inconclusive.The device in question, used in the procedure, is not available for evaluation by conmed.No photographic evidence has been provided.Therefore, the reported failure cannot be verified, and root cause can not be identified.As a lot number was not provided, conmed could not conduct a two-year lot history review or review the manufacturing documents from the device history record.(b)(4).The instructions for use (ifu) provides the user with information regarding proper care and use of this device.Also per the ifu the user is advised that the guidewire should not be advanced if resistance is met without determining the cause and taking remedial action.Before and 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 and the soldered joints between the spring tip and 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.

• Brand Name: SPRING TIP MARKED GUIDEWIRE
• Type of Device: DILATOR, ESOPHAGEAL
• Manufacturer (Section D): CONSOLIDATED MEDICAL EQUIPMENT; alejandro dumas ave, 11321; complejo industrial chihuahua; chihuahua, mexico 31136 ; MX 31136
• MDR Report Key: 11575855
• MDR Text Key: 258048914
• Report Number: 3007305485-2021-00139
• 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: company representative,health
• Type of Report: Initial,Followup
• Report Date: 04/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 000150
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/01/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Other