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

Model Number	7264V
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Vessel Or Plaque, Device Embedded In (1204)
Date of Event	05/22/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has not returned for evaluation.The manufacturing record review was completed.From the information received an internal corrective action was initiated.A follow-up report will be submitted if the complaint device returns for investigation.
Event or Problem Description
As reported: physician was attempting to gain access to rfa with the micro-introducer.It is reported, that the patient had a lot of fibrous tissue.During use, the micro-introducer hub broke off and the shaft remained in the patient; the case was aborted, and patient was sent to the or to remove shaft.Additional information received 18jun2020: patient was fine after leaving the operating room.Reported that the patient was stable the whole time, and no residual issues since.
Additional Manufacturer Narrative
The product was returned and inspected.The returned product evaluation confirmed the sheath was separated near the proximal hub.The hub shaft bond was not where the separation occurred.The proximal shaft looks as if it was sliced or cut.There were also kinks found in the shaft of the sheath.The kinks could have most likely occurred during shaft removal.The account was contacted to confirm whether there was a use of a scalpel during the access procedure with the sheath.No response was received.It was determined that the failure was not manufacturing related, however, associated to operational context or unintended use error.

• Brand Name: MICRO-INTRODUCER KIT
• Common Device Name: CATHETER
• Manufacturer (Section D): VASCULAR SOLUTIONS, LLC; 6464 sycamore court north; minneapolis, mn
• MDR Report Key: 10173596
• Report Number: 2134812-2020-00037
• Device Sequence Number: 3560946
• Product Code: DYB
• UDI-Device Identifier: 20841156102897
• UDI-Public: 20841156102897
• Combination Product (Y/N): N
• 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,Followup
• Report Date (Section B): 05/22/2020

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: Health Professional
• Device Expiration Date: 04/30/2022
• Device Model Number: 7264V
• Device Lot Number: 651793
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2020
• Initial Date Received by Manufacturer: 05/22/2020
• Supplement Date Received by Manufacturer: 05/22/2020
• Initial Report FDA Received Date: 06/19/2020
• Supplement Report FDA Received Date: 08/10/2020
• 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: 69 YR
• Patient Weight: 82