MAUDE Adverse Event Report: MEDSPIRA LLC MCOMPASS BIOFEEDBACK 2-CHANNEL CATHETER; DEVICE, BIOFEEDBACK

Model Number RMD-002-004

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/07/2019

Event Type  malfunction  

Event Description

During biofeedback session, balloon part of the biofeedback catheter broke while in the patient.Manufacturer response for anorectal manometry catheter, mcompass biofeedback 2 channel anorectal manometry catheter (per site reporter).This is the fifth case of this type for this particular device experienced by (b)(6) hospitals over the past six weeks.Company has been made aware and has made arrangements to replace all existing stock with this additional lot number (see previous report).Unaware if other follow up has occurred.

• Brand Name: MCOMPASS BIOFEEDBACK 2-CHANNEL CATHETER
• Type of Device: DEVICE, BIOFEEDBACK
• Manufacturer (Section D): MEDSPIRA LLC; 2718 summer street ne; minneapolis MN 55413
• MDR Report Key: 8394217
• MDR Text Key: 137973579
• Report Number: 8394217
• Device Sequence Number: 1
• Product Code: HCC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/18/2019,02/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RMD-002-004
• Device Catalogue Number: RMD-002-004
• Device Lot Number: 19011401
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/18/2019
• Event Location: Hospital
• Date Report to Manufacturer: 03/06/2019
• 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: 13140 DA