MAUDE Adverse Event Report: MEDRON, LLC; MINI STICK 4.0 F X 10CM STIFF INTRODUCER

Model Number 1331-002

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/08/2018

Event Type  malfunction  

Manufacturer Narrative

Medorn is a contract manufacturer and does not own the design of the device and does not sell the device to end users.When a failure occurs, medron assesses the device history record and the physical sample (when available).(b)(4).

Event Description

Medron was notified by angio dynamics that "we received a customer complaint stating that "on (b)(6) 2018, a (b)(6) female with an extensive vascular history underwent an attempted catheterization using a mini stick max via left femoral access.As the interventionalist attempted to pull out the micropuncture sheath, the proximal portion snapped off leaving the majority of the sheath in situ.The retained sheath could not be visualized (not radiopaque under fluoroscopy.) the patient was taken to the or for a surgical cutdown, placement of a bovine patch and sheath removal.We are returning one 4f introducer for evaluation.The 4f introducer has been disinfected using a 1:10 bleach and water mixture and placed in our oven for 1 hour to dry but should be considered bio-hazard materials.Pease perform an evaluation of the returned sample, a dhr review for the noted lot {170269}.".

• Type of Device: MINI STICK 4.0 F X 10CM STIFF INTRODUCER
• Manufacturer (Section D): MEDRON, LLC; 1518 s gladiola street; salt lake city 84104
• Manufacturer (Section G): MEDRON, LLC; 1518 s gladiola street; salt lake city 84104
• Manufacturer Contact: david kujawa ; 1518 s gladiola street; salt lake city, UT 84104 ; 8019743010
• MDR Report Key: 7758923
• MDR Text Key: 116899338
• Report Number: 1722746-2018-00011
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/08/2018

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
• Device Operator: No Information
• Device Model Number: 1331-002
• Device Lot Number: 170269
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2018
• Initial Date Manufacturer Received: 07/20/2018
• Initial Date FDA Received: 08/07/2018
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1