MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; CLOSUREFAST PROCEDURE PACK-LF

Catalog Number	DYNJ0365463G
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	08/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was initially reported that a patient with pseudo aneurysm had radiofrequency ablation of great saphenous vein, where local anesthesia and transducer compression were used.Per report, "either the tumescent needles or the stab phlebotomy (carried out after rf ablation) nicked the artery." despite good faith efforts to obtain additional information, no further patient, product, procedural or event details are available.It is unknown which needle or sharp from the custom surgical pack was being used at the time of the incident and what device failure or issue was noted that was associated with this adverse event.There is also no available information on what medical intervention was required for the reported nicked artery.Due to the reported nicked artery, this medwatch is being filed.A sample has not been returned for evaluation.A definitive root cause for the reported issue 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, "either the tumescent needles or the stab phlebotomy (carried out after rf ablation) nicked the artery.".

• Common Device Name: CLOSUREFAST PROCEDURE PACK-LF
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 9156136
• Report Number: 1423395-2019-00039
• Device Sequence Number: 11400394
• Product Code: LRO
• UDI-Device Identifier: 10889942059508
• UDI-Public: 10889942059508
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/04/2019

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: DYNJ0365463G
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/05/2019
• Initial Report FDA Received Date: 10/04/2019
• 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: Other