MAUDE Adverse Event Report: CONSOLIDATED MEDICAL EQUIPMENT COMPANY DISPOSABLE MARKED SPRING TIP GUIDEWIRE; ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY

Catalog Number DIS150

Device Problem Fracture (1260)

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

Event Date 10/28/2021

Event Type  malfunction  

Manufacturer Narrative

At time of filing, although expected, the reported device has not been received into conmed¿s complaint system for evaluation.A supplemental and final report will be filed following the completion of the device evaluation and complaint investigation.This issue will continue to be monitored through the complaint system to assure patient safety.

Event Description

The customer reported issues with the disposable marked springtip guidewire, item # dis150, lot 202106115, recently experienced by (b)(6) hospital, (b)(6) on (b)(6) 2021.Information received was that during a gi endoscopy procedure, the spring tip guidewire ¿popped off & was un-usable".Clarification received noted that the device partially snapped in the spring tip.The spring tip guidewire was in the patient when the spring tip issue occurred.It did not fall off, only partially broke.No unusual anatomy was noted for patient.All the pieces were removed from the patient, retracted through the scope.It is noted the patient is fine / there was no patient injury.The procedure was completed.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence as the device broke/cracked but did not fall off into the patient.

Manufacturer Narrative

Investigation of the customer's complaint of the guidewire tip breaking off is confirmed.Conmed received one dis150 in opened original packaging.The lot number was verified against documents returned with the device.A visual inspection was performed.The spring at the tip of the guidewire is broken but not detached; evaluation photographs show the spring tip was bent.The returned device exhibits the reported claim, nevertheless a root cause cannot be established.The manufacturing documents from the device history record have been reviewed and found no abnormalities that would contribute to this issue.A two-year lot history review was conducted and found 2 similar events reported for this lot number.A two-year review of complaint history revealed there has been a total of 13 complaints, regarding 22 devices, for this device family and failure mode.During this same time frame 35,278 devices have been manufactured and shipped worldwide.Should all the complaint devices have been found confirmed for this reported failure, the rate of failure would be 0.0006.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.

Event Description

The customer reported issues with the disposable marked springtip guidewire, item # dis150, lot 202106115, recently experienced by (b)(6) on (b)(6) 2021.Information received was that during a gi endoscopy procedure, the spring tip guidewire ¿popped off & was un-usable".Clarification received noted that the device partially snapped in the spring tip.The spring tip guidewire was in the patient when the spring tip issue occurred.It did not fall off, only partially broke.No unusual anatomy was noted for patient.All the pieces were removed from the patient, retracted through the scope.It is noted the patient is fine / there was no patient injury.The procedure was completed.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence as the device broke/cracked but did not fall off into the patient.

• Brand Name: DISPOSABLE MARKED SPRING TIP GUIDEWIRE
• Type of Device: ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): CONSOLIDATED MEDICAL EQUIPMENT COMPANY; ave. alejandro dumas 11321; complejo industrial chihuahua; chihuahua 31136 ; MX 31136
• Manufacturer (Section G): CONSOLIDATED MEDICAL EQUIPMENT COMPANY; ave. alejandro dumas 11321; complejo industrial chihuahua; chihuahua 31136 ; MX 31136
• Manufacturer Contact: tracey weiselbenton ; conmed corporation; 11311 concept blvd; largo, FL 33773 ; 7273995557
• MDR Report Key: 12855083
• MDR Text Key: 285558127
• Report Number: 3007305485-2021-00413
• Device Sequence Number: 1
• Product Code: OCY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 01/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/11/2023
• Device Catalogue Number: DIS150
• Device Lot Number: 202106115
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/21/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/11/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Ethnicity: Non Hispanic