MAUDE Adverse Event Report: CURE MEDICAL LLC CURE CATHETER; URINARY CATHETER

Model Number	M10
Medical Device Problem Codes	Material Separation (1562); Cut In Material (2454)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	09/25/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An incomplete used device was returned.Evaluation of returned incomplete device confirmed catheter tip detached.The original device packaging was not returned.User stated he did not examine catheter or packaging before use.Since an incomplete device was returned and the user is unable to provide details of the condition of the device prior to use, only a partial device evaluation is possible.The partial device evaluation is insufficient to determine the root cause of the defect.
Event or Problem Description
User/patient had difficulty placing catheter and when nurse removed it from the monti channel she noticed the tip was broken off.User did not examine catheter or packaging prior to use.Eighteen days after the event the patient underwent a cytoscopy to remove the catheter tip from his bladder during a scheduled surgical procedure unrelated to the event.Event did not affect ability to catheterize patient.The catheter tip was successfully removed during the procedure without complication.

• Brand Name: CURE CATHETER
• Common Device Name: URINARY CATHETER
• Manufacturer (Section D): CURE MEDICAL LLC; 3471 via lido, #211; newport beach CA 92663
• MDR Report Key: 6985594
• Report Number: 3005471919-2017-00004
• Device Sequence Number: 10892372
• Product Code: EZD
• UDI-Device Identifier: 00815947020017
• UDI-Public: (01)00815947020017(17)220228(10)170303-1(241)M10
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K072539
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 10/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 02/28/2022
• Device Model Number: M10
• Device Catalogue Number: M10
• Device Lot Number: 170303-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/27/2017
• Initial Report FDA Received Date: 10/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 6 YR
• Patient Weight: 16