MAUDE Adverse Event Report: GIVEN IMAGING INC. MANOSCAN ESO Z CATHETER; SYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL)

Device Problems Difficult to Remove (1528); Sticking (1597)

Patient Problem Blood Loss (2597)

Event Date 08/31/2016

Event Type  malfunction  

Event Description

Esophageal manometry probe was placed during egd.Manometry study was conducted without incident.Upon removal of the esophageal manometry probe, the probe was stuck and unable to be removed.Several attempts were made to dislodge to the probe with the patient different positions, i.E.Left and right lateral position, chin tuck down or tilted up, head turned to left and right.The doctor was notified and assessed the patient.He too tried to remove the probe, but was unsuccessful.Doctor spoke with the doctor who placed the manometry probe during egd.The patient was brought to radiology for chest x-ray to assess probe placement.Doctors spoke with ent department.The doctor from ent came to assess probe placement in gi clinic.The doctor from ent was also unable to remove probe while in gi clinic.The patient was brought up to ent clinic where the probe was removed successfully.The patient suffered a small nose bleed was noted which stopped by the time the patient left the gi clinic.

• Brand Name: MANOSCAN ESO Z CATHETER
• Type of Device: SYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL)
• Manufacturer (Section D): GIVEN IMAGING INC.; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 6069500
• MDR Text Key: 58849640
• Report Number: 6069500
• Device Sequence Number: 1
• Product Code: FFX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2016
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2016
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/19/2016
• Event Location: Hospital
• Date Report to Manufacturer: 09/19/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 38 YR