MAUDE Adverse Event Report: MMJ SA DE CV (USD) FOLEY CATHETER W TEMP; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number 90055T

Device Problem Connection Problem (2900)

Patient Problems Death (1802); Foreign Body In Patient (2687)

Event Type  malfunction  

Manufacturer Narrative

This product is not sold in us and is 510(k) exempt.This report is associated to a similar product sold in the us - 510(k) number k831567.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during a normal use, the patient had worrying movement patterns which moved the catheter and broke.It was reported that 10 to 15 cm of the catheter was still in the urethra or bladder.Customer reported that the patient was in palliative state; thus, was deemed not appropriate for further action.It was indicated that the patient was deceased but this was not related to the device.

Manufacturer Narrative

Evaluation summary: medtronic conducted an investigation based upon all information received.The device was not returned, but a photo was available for evaluation.Visual inspection of the picture found the device was broken.The condition of the catheters deformed sensor wire can occur if the device was pulled strongly during use.A retain sample from the same lot was examined and no issues were found.It was reported that the catheter broke.The reported issue was confirmed.The most likely cause could not be established from the information available.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.If information is provided in the future, a supplemental report will be issued.

• Brand Name: FOLEY CATHETER W TEMP
• Type of Device: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): MMJ SA DE CV (USD); ave henequen no 1181 desarroll; ciudad juarez 32590 ; MX 32590
• Manufacturer (Section G): MMJ SA DE CV (USD); ave henequen no 1181 desarroll; ciudad juarez 32590 ; MX 32590
• Manufacturer Contact: avi kluger ; 5920 longbow drive; boulder, CO 80301 ; 3035306582
• MDR Report Key: 8056962
• MDR Text Key: 127077265
• Report Number: 2936999-2018-00679
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: SW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2023
• Device Model Number: 90055T
• Device Catalogue Number: 90055T
• Device Lot Number: S18006674
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2019
• Initial Date Manufacturer Received: 10/12/2018
• Initial Date FDA Received: 11/09/2018
• Supplement Dates Manufacturer Received: 12/10/2018
• Supplement Dates FDA Received: 12/18/2020
• Was Device Evaluated by Manufacturer?: Yes
• 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 Age: 92 YR
• Patient Weight: 97