MAUDE Adverse Event Report: LABORIE MEDICAL TECHNOLOGIES CANADA ULC LATORIE; ABDOMINAL PRESSURE CATHETER 9F

Model Number RPC-9

Device Problem Loss of or Failure to Bond (1068)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/02/2015

Event Type  malfunction  

Event Description

During a urodynamics procedure, when the rectal balloon catheter was removed from the patient at the end of the procedure, the balloon part separated from the catheter and remained in the patient.Patient was sent next door to the surgery center so a physician could remove the balloon.

• Brand Name: LATORIE
• Type of Device: ABDOMINAL PRESSURE CATHETER 9F
• Manufacturer (Section D): LABORIE MEDICAL TECHNOLOGIES CANADA ULC; 6415 northwest dr., unit 11; mississauga, on L4V1X 1; CA L4V1X1
• Manufacturer (Section G): IMAK MEXICANA, S. DE R.L. DE C.V.; breche e-99 norte edificio 5; parque industrial reynosa; reynose, tamaulipas, c.p. 8878 0; MX 88780
• Manufacturer Contact: gerald loney ; 6415 northwest dr., unit 11; mississauga, on L4V 1-X1 ; CA L4V 1X1 ; 6121170
• MDR Report Key: 4648808
• MDR Text Key: 5685661
• Report Number: 9681424-2015-00003
• Device Sequence Number: 1
• Product Code: FEN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 03/19/2015

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: 11/01/2017
• Device Model Number: RPC-9
• Device Catalogue Number: RPC-9
• Device Lot Number: CM14119
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/11/2015
• Date Manufacturer Received: 03/02/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/01/2014
• 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