MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; TOWEL,OR,DSP,ST,GREEN,DLX,4/PK,20PK/CS

Catalog Number	MDT2168104
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that during a percutaneous coronary intervention (pci) procedure the physician noted that the opened vessel had "shut down." the physician performed a thrombectomy and reportedly removed linted or material from the vessel.The patient was not under general anesthesia at the time of the incident.The pci procedure was completed without further reported incident.After an unidentified period of time, the facility contact noted that the patient was required to return to the procedure room for additional intervention as the vessel was found to have occluded.It was not indicated if or towel material was found or required to be removed from the vessel during the second, unidentified, cardiac procedure.No additional information related to the second, unidentified, cardiac procedure was reported to the manufacturer.The manufacturer did not receive information indicating that the originally reported linted or material caused and/or contributed to the second, unidentified, cardiac procedure.Although samples from various lots were returned, the original or towel sample involved in this incident was not returned to the manufacturer for evaluation.Investigation of the returned samples noted loose threads on the or towel with no linting noted.A root cause could not be determined.Due to the reported incident and the need for medical intervention to remove the linted or material from the vessel, this medwatch is being filed.If additional information becomes available a supplemental medwatch will be filed.
Event or Problem Description
It was reported that during a percutaneous coronary intervention (pci) procedure or towel material was found to have linted into a vessel.

• Common Device Name: TOWEL,OR,DSP,ST,GREEN,DLX,4/PK,20PK/CS
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• MDR Report Key: 7991555
• Report Number: 1417592-2018-00111
• Device Sequence Number: 1682552
• Product Code: FRL
• UDI-Device Identifier: 20080196743473
• UDI-Public: 20080196743473
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 10/22/2018

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: MDT2168104
• Device Lot Number: 18GB0443
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/25/2018
• Initial Report FDA Received Date: 10/22/2018
• 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: Required Intervention
• Patient Age: 89 YR
• Patient Weight: 68