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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONSOLIDATED MEDICAL EQUIPMENT COMPANY MARKED GUIDEWIRE (2/CS); DILATOR, ESOPHAGEAL
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CONSOLIDATED MEDICAL EQUIPMENT COMPANY MARKED GUIDEWIRE (2/CS); DILATOR, ESOPHAGEAL Back to Search Results
Catalog Number 000150
Device Problem Material Fragmentation (1261)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/01/2023
Event Type  malfunction  
Event Description
This complaint was created due to the receipt of a medwatch report mw5114737 on 16feb23.The report was found to be written against 000150, marked guidewire (2/cs) that was being used during an egd procedure on (b)(6) 2023.The report stated, ¿during an egd (upper scope) procedure, the spring tip broke off the guidewire during esophageal dilation and fell into the patient¿s stomach.The spring wire tip was completely retrieved and visualized.¿ there was no report of injury, medical intervention, or extended hospitalization to the patient or user.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
 
Manufacturer Narrative
The device is not expected to be returned for evaluation and review.However, the complaint investigation is not complete at this time.A supplemental and final report will be filed following the completion of the complaint investigation.We will continue to monitor for trends through the complaint system to assure patient safety.
 
Manufacturer Narrative
The device will not be returned and no photographic evidence has been provided therefore the reported event cannot be verified.(b)(4).Per the instructions for use, the user is advised the following: the guidewire should not be advanced if resistance is met without determining the cause and taking remedial action.Carefully inspect the unit to verify that the sterile package of the product has not been damaged in shipment.Remove the guidewire from packaging and remove the tape attached to wire.Carefully inspect it for any damage that may have occurred during transit or handling.Carefully examine the guide wire and also test the tip of guidewire for integrity before each use to avoid detachment inside patients.If the tip of the guidewire exhibits wear, damage, abnormal bending of the joints appears discolored, loose or cracked, discard and do not use the device.Guidewire is inserted through the biopsy channel of an endoscope with the spring tip to be located just past the esophogastric (e.G.) junction into the gastric cavity.The endoscope is then withdrawn.The guidewire should be monitored externally using markings as dental arch reference points before and during dilatation.We will continue to monitor for trends through the complaint system to assure patient safety.
 
Event Description
This complaint was created due to the receipt of a medwatch report mw5114737 on 16feb23.The report was found to be written against 000150, marked guidewire (2/cs) that was being used during an egd procedure on (b)(6) 2023.The report stated, ¿during an egd (upper scope) procedure, the spring tip broke off the guidewire during esophageal dilation and fell into the patient¿s stomach.The spring wire tip was completely retrieved and visualized.¿ there was no report of injury, medical intervention, or extended hospitalization to the patient or user.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
 
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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
Manufacturer (Section G)
CONSOLIDATED MEDICAL EQUIPMENT COMPANY
ave. alejandro dumas 11321
complejo industrial chihuahua
chihuahua 31136
MX   31136
Manufacturer Contact
samantha dewberry
525 french road
utica, NY 13502
3152230184
MDR Report Key16490095
MDR Text Key311098924
Report Number3007305485-2023-00048
Device Sequence Number1
Product Code KNQ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K853274
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other
Reporter Occupation Administrator/Supervisor
Type of Report Initial,Followup
Report Date 03/27/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/06/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number000150
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received03/07/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Patient Sequence Number1
Patient EthnicityNon Hispanic
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