MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; ANGIOGRAPHIC PACK II-LF

Catalog Number	DYNJ0543507AA
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/20/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that, during a diagnostic heart catheterization procedure, lint went into a patient's coronary artery and became lodged into the distal left anterior descending coronary artery.The surgeon reported that lint was not noted on the wire, but a lucency was visualized in the coronary artery after the percutaneous coronary intervention (pci) was complete.The physician feels that a piece of lint was advanced over the wire and into the artery causing a problem in an area that did not have any noted disease.The reported incident did cause an unspecified injury to the patients left anterior descending artery (lad) and prolonged the time it took to complete the procedure which increased the patient's exposure to radiation.The pci procedure was completed without further reported incident; however after an unidentified period of time, the facility contact noted that the patient was required to return to the emergency room (er) for follow-up care due to chest pain.The physician reported that the patient is doing fine at this time.The patient was not under general anesthesia at the time of the incident.It was not indicated if the operating room (or) towel material was found or required to be removed from the vessel.Despite multiple good faith efforts to obtain additional information, the customer contact was unable or unwilling to provide further patient details to the manufacturer.The manufacturer did not receive information confirming that the reported linted or towel material caused and/or contributed to procedure.No additional information was available at the time of this report.The sample of the reported towel was not returned to the manufacturer for evaluation.A root cause could not be determined.Due to the reported incident and the need for medical intervention, 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 diagnostic heart catheterization procedure or towel material was thought to have linted into a vessel.

• Common Device Name: ANGIOGRAPHIC PACK II-LF
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 8386963
• Report Number: 1423395-2019-00006
• Device Sequence Number: 1785658
• Product Code: OEQ
• UDI-Device Identifier: 10889942769124
• UDI-Public: 10889942769124
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 03/04/2019

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: DYNJ0543507AA
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/25/2019
• Initial Report FDA Received Date: 03/04/2019
• 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