MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; OR TOWEL IN CARDIAC CATH PACK

Catalog Number	DYNJ30213I
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/25/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that or towel lint was discovered on a cardiac guidewire during a percutaneous coronary intervention (pci) procedure.According to the facility contact, during the procedure, an unsuccessful attempt was made to pass the pci balloon over the cardiac guidewire.When the cardiac guidewire was removed from the patient, or towel lint was reportedly discovered on the wire.A new cardiac guidewire was obtained without further incident reported.It was reported that there was a delay in opening the artery and that the patient was "on table longer than needed." information regarding the length of the delay and the overall length of the procedure was not provided.The facility contact denies any serious injury, medical intervention, or follow-up care related to the reported incident.No impact to the patient, the patient's stability, or the patient's plan of care was reported.Only the cardiac guidewire was returned to the manufacturer for evaluation.A small piece of or towel lint was found on a section of the cardiac guidewire.The original or towel sample involved in this incident was not returned to the manufacturer for evaluation.A root cause could not be determined.Due to the reported incident, and in an abundance of caution, this medwatch is being filed.If additional information becomes available a supplemental medwatch will be filed.
Event or Problem Description
It was reported that or towel lint was discovered on a cardiac guidewire during a percutaneous coronary intervention (pci) procedure.

• Common Device Name: OR TOWEL IN CARDIAC CATH PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• MDR Report Key: 7804359
• Report Number: 1423395-2018-00043
• Device Sequence Number: 11026095
• Product Code: OES
• UDI-Device Identifier: 10889942765027
• UDI-Public: 10889942765027
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Other Health Care Professional
• Type of Report: Initial

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
• Operator of Device: Health Professional
• Device Catalogue Number: DYNJ30213I
• Device Lot Number: 18FDA068
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/02/2018
• Initial Report FDA Received Date: 08/22/2018
• 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