MAUDE Adverse Event Report: CLLINICAL INNOVATIONS T-DOC; ANORECTAL MANOMETRY CATHETER

Model Number T-DOC-ARM4

Device Problem Loss of or Failure to Bond (1068)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/10/2015

Event Type  malfunction  

Event Description

While performing an anorectal manometry diagnostic procedure, the balloon on the end of the catheter became dislodged.

Manufacturer Narrative

When the patient stood up, the catheter fell out.The balloon must have come off prior to then.We were doing the sensations test and the rectal balloon was inflated slowly.We never filled the balloon past 300 cc but the patient did not have a sensation of filling.We surmise that the balloon came off during that filling.We were going to do the expulsion test by injecting 50 cc of air into the rectal balloon and have the patient attempt to expel it in the restroom.But when the patient got up off the exam table to go to the restroom, it was then that the catheter fell out of the rectum and the balloon was missing.The doctor tried to find the balloon digitally, but could not feel it.The patient was also asked to try to expel it by straining, but the balloon was not expelled.The patient was instructed to try to expel it at home over night, but if she did not do so, she was to return to the clinic and the doctor was going to use a scope to try and find it.We do not know the outcome after this.

• Brand Name: T-DOC
• Type of Device: ANORECTAL MANOMETRY CATHETER
• Manufacturer (Section D): CLLINICAL INNOVATIONS; 747 w 4170 s; murray UT 84123
• Manufacturer (Section G): CLINICAL INNOVATIONS; 747 w 4170 s; murray UT 84123
• Manufacturer Contact: gerald loney ; 6415 northwest dr.; mississauga, on L4V 1-X1 ; CA L4V 1X1 ; 6121170
• MDR Report Key: 4648807
• MDR Text Key: 21843296
• Report Number: 9681424-2015-00002
• Device Sequence Number: 1
• Product Code: FFX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K963064
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date: 03/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2016
• Device Model Number: T-DOC-ARM4
• Device Catalogue Number: CAT003
• Device Lot Number: 140500
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/19/2015
• Date Manufacturer Received: 03/03/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/01/2014
• 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): Other