MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; CATH N0 1 STRL MMC PACK

Catalog Number	DYNJ46134C
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/19/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that during a left heart catheterization with intervention, upon removal of the catheter from the patient, a "thrombus" was noted on the catheter, reportedly from the linting of blue or towel.Per report, the blue or towel was inspected before use and linting was not identified at that time.It was denied that the towel was used to wipe the catheter.Per report, the facility was able to pull out the "thrombus"on the catheter; however, was unable to determine if any lint remained in the patient.The patient did not require additional sedation as a result of this incident.The patient was discharged to home following the procedure.There was no serious injury reported.Due to the reported incident and in an abundance of caution, this medwatch is being filed.The sample was discarded and was not returned for evaluation.A root cause could not be determined at this time.No additional information is available.If additional information becomes available, a supplemental medwatch will be filed.
Event or Problem Description
It was reported that during a left heart catheterization with intervention, upon removal of the catheter from the patient, a "thrombus" was noted on the catheter, reportedly from the linting of blue or towel.

• Common Device Name: CATH N0 1 STRL MMC PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 7682779
• Report Number: 1423395-2018-00038
• Device Sequence Number: 16370333
• Product Code: OES
• UDI-Device Identifier: 10889942610822
• UDI-Public: 10889942610822
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 07/12/2018

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: Health Professional
• Device Catalogue Number: DYNJ46134C
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/21/2018
• Initial Report FDA Received Date: 07/12/2018
• 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: 65 YR
• Patient Weight: 76