MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC. MEDLINE INDUSTRIES, INC.; ANGIO PROCEDURE PACK

Model Number	00-401824Y
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/12/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported the hub broke off the guidewire sheath while in the patient.The reporter states the incident occurred during the middle of a procedure, "no report of injury occurred as we were able to remove the broken sheath before it caused harm".The reporter states the patient is doing well.The sample has not been return for evaluation.Therefore, a root cause has not been established.No further information is available at this time.Due to the nature of the incident and in 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 the hub broke off the guidewire sheath while in the patient.The reporter states the incident occurred during the middle of a procedure, "no report of injury occurred as we were able to remove the broken sheath before it caused harm".

• Brand Name: MEDLINE INDUSTRIES, INC.
• Common Device Name: ANGIO PROCEDURE PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield, il
• MDR Report Key: 10225285
• Report Number: 1423395-2020-00013
• Device Sequence Number: 2842258
• Product Code: LRO
• UDI-Device Identifier: 10889942784363
• UDI-Public: 10889942784363
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/02/2020

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 Model Number: 00-401824Y
• Device Catalogue Number: 00-401824Y
• Device Lot Number: 20DBT822
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/12/2020
• Initial Report FDA Received Date: 07/02/2020
• 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: 55 YR
• Patient Weight: 77