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

Model Number 00-401824Y

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/12/2020

Event Type  malfunction  

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 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.
• Type of Device: ANGIO PROCEDURE PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield, il
• Manufacturer Contact: teresa maynard ; three lakes drive; northfield, il ; 9311514
• MDR Report Key: 10225285
• MDR Text Key: 200409782
• Report Number: 1423395-2020-00013
• Device Sequence Number: 1
• Product Code: LRO
• UDI-Device Identifier: 10889942784363
• UDI-Public: 10889942784363
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 00-401824Y
• Device Catalogue Number: 00-401824Y
• Device Lot Number: 20DBT822
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/12/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR
• Patient Weight: 77