MAUDE Adverse Event Report: GIVEN GILA (LOS. ANGELES) MANOSCAN ESO Z CATHETER; SYSTEM, GASTROINTESTIONAL MOTILITY (ELECTRICAL)

Model Number 3890

Device Problem Break (1069)

Patient Problem No Code Available (3191)

Event Date 10/11/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).(additional anesthesia was required while the catheter was removed from the patient; there was no harm to the patient).

Event Description

According to the reporter, the catheter got stuck in the patient's nasal passage.The patient was numbed and well lubricated but they could still not get the catheter out.They had to pull the probe out of the patient's mouth then cut it in half to remove it.The catheter got stuck in the patient after the procedure was completed.There was no bleeding.The patient was offered a referral to an ent but the patient declined.An extra 1ml of 4% lidocaine+afrin mixture was given to the patient to remove the catheter.The last known patient status is that the patient is currently doing well.Additional information was requested from the account; should we receive additional information, a supplemental mdr will be submitted.

• Brand Name: MANOSCAN ESO Z CATHETER
• Type of Device: SYSTEM, GASTROINTESTIONAL MOTILITY (ELECTRICAL)
• Manufacturer (Section D): GIVEN GILA (LOS. ANGELES); 5860 uplander way; culver city CA 90230
• Manufacturer (Section G): GIVEN GILA (LOS. ANGELES); 5860 uplander way; culver city CA 90230
• Manufacturer Contact: sharon murphy ; 195 mcdermott rd.; north haven, CT 06473 ; 2034925267
• MDR Report Key: 6081502
• MDR Text Key: 59283793
• Report Number: 3005344223-2016-00003
• Device Sequence Number: 1
• Product Code: FFX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091070
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 3890
• Device Catalogue Number: 3890
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/18/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 63 YR