MAUDE Adverse Event Report: VASCULAR SOLUTIONS, INC MICRO-INTRODUCER; INTRODUCER CATHETER

Model Number	7272X
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/04/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the device history records was performed for the indicated packaging and component lots for any deviations related to the reported defect of the complaint.The review confirms that the lots met all material, assembly and performance specifications.The device was being used for treatment and was directly related to the failure.The returned product evaluation confirmed the broken wire.The dilator was also broken in two pieces and the tip remained on the wire.The separation point on the wire had a slight bend to it confirming the wire was kinked prior to breaking.Based on the information stating that physician pulled "hard" to remove the wire and the warning provided in the instructions for use, the most likely root cause is misuse.
Event or Problem Description
The blue inner dilator bent, and today they got the wire stuck and then it broke off inside the patient.Physician did retrieve the wire.Per physician the wire looped in the graft, because of the loop/kink the wire wouldn't pull out.He pushed forward and then pulled back hard and it fractured.He snared with a snare device.It fractured in the stiff part of the wire.It was stuck in a clotted graft and said he pulled pretty hard and had no problem if he had to snare it.No harm or delay in treatment to the patient.The case was finished.Additional information rec'd 05jun18: he was a declot patient, in operating room.We used the micro then used the blue dilator and wire in pre-accessed site to put in 7fr sheath.Then got a 2nd access using the access kit.Needle wire, blue dilator and white dilator.Then switched to another 7fr sheath.The wire got stuck, and the blue dilator bent.The tip of the blue broke off, and the wire broke off, both inside of the patient.Physician then successfully snared the wire, which had the tip of the broken blue dilator on it.

• Brand Name: MICRO-INTRODUCER
• Common Device Name: INTRODUCER CATHETER
• Manufacturer (Section D): VASCULAR SOLUTIONS, INC; 6464 sycamore court north; minneapolis MN 55369
• MDR Report Key: 7659262
• Report Number: 2134812-2018-00042
• Device Sequence Number: 1108609
• Product Code: DYB
• UDI-Device Identifier: M2067272X0
• UDI-Public: M2067272X0
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K180913
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/04/2018

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?: Yes
• Operator of Device: Physician
• Device Expiration Date: 04/03/2021
• Device Model Number: 7272X
• Device Lot Number: 623366
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/04/2018
• Initial Report FDA Received Date: 07/03/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention