MAUDE Adverse Event Report: UNITED STATES ENDOSCOPY GROUP, INC. CARR-LOCKE INJECTION NEEDLE

Model Number 00711812

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Dyspnea (1816)

Event Date 12/30/2015

Event Type  Injury  

Manufacturer Narrative

Us endoscopy received a report that following the use of a 23 gauge carr-locke injection needle to inject histoacryl (n-butylcyanoacrylate) glue in the treatment of gastric varices, the patient developed shortness of breath that the physician attributed to a glue embolus.The patient was an inpatient at the hospital and remained so after the procedure.No treatment was performed as a result of the glue embolus and there was no reported harm to the patient.The device was discarded by the user and there was no indication that the device malfunctioned.The subject device was not returned for evaluation.The manufacturing record for the device was reviewed and found no manufacturing or quality problems; all inspections were completed and acceptable results were documented.The ifu indicates "the carr-locke 23 gauge injection needle (product #00711812, #00711814, #00711824) is compatible with hyaluronic acid, hydroxypropyl methylcellulose, glycerine, lipiodol, and n-butylcyanoacrylate.Note: lipiodol and n-butylcyanoacrylate have not been approved by the united states federal food and drug administration and should not be used in endoscopic procedures." this information will be presented to the customer.Device not returned to manufacturer.

Event Description

The carr-locke injection needle is intended to be used for the injection of various types of media through flexible endoscopes.Us endoscopy received a report that following the use of a 23 gauge carr-locke injection needle to inject histoacryl (n-butylcyanoacrylate) glue in the treatment of gastric varices, the patient developed shortness of breath that the physician attributed to a glue embolus.The patient was an inpatient at the hospital and remained so after the procedure.No treatment was performed as a result of the glue embolus and there was no reported harm to the patient.The device was discarded by the user and there was no indication that the device malfunctioned.

• Brand Name: CARR-LOCKE INJECTION NEEDLE
• Type of Device: INJECTION NEEDLE
• Manufacturer (Section D): UNITED STATES ENDOSCOPY GROUP, INC.; 5976 heisley rd; mentor OH 44060
• Manufacturer (Section G): UNITED STATES ENDOSCOPY GROUP, INC.; 5976 heisley rd; mentor OH 44060
• Manufacturer Contact: coletta cohara ; 5976 heisley road; mentor, OH 44060 ; 4403586251
• MDR Report Key: 5394531
• MDR Text Key: 36956196
• Report Number: 1528319-2016-00002
• Device Sequence Number: 1
• Product Code: FBK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K971842
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 12/31/2018
• Device Model Number: 00711812
• Device Catalogue Number: 00711812
• Device Lot Number: 1519278
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/02/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/07/2015
• 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 Outcome(s): Hospitalization