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

Model Number	7280V
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body Embolism (4439)
Date of Event	07/15/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Preliminary manufacturing record was reviewed, there were no nonconformance related to this lot, therefore, supporting the device met material, assembly and performance specifications.A follow-up report will be issued after the investigation is complete.
Event or Problem Description
Per medwatch received 29sep2020 medwatch (b)(4).Per medwatch form: per surgeon's op note: the 21 gauge needle of the microcatheter introducer kit was used to cannulize the left subclavian vein, which was done easily.We had good blood return.The fine wire of the microcatheter introducer kit was then threaded through the 21 gauge needle.The wire would not pass.The needle was withdrawn.Upon attempting to remove the wire, it seemed to be stuck in the clavipectoral fascia.We employed fluoroscopy and indeed it appeared that the very flexible tip of this fine j-wire had actually doubled back and even knotted on itself.It could not be retrieved manually.For this reason, after infiltrating additional local anesthesia, i extended the port pocket incision in the left infraclavicular space.A combination of sharp and blunt dissection was used to dissect down to the clavicle at the entry site of the wire.Using fluoroscopy, we determined the exact location of this coiled and knotted tip of the wire and it was removed with blunt and sharp dissection from the clavipectoral fascia.It was actually removed in 2 small pieces at the tip.We employed fluoroscopy to identify the location and triangulate the location, which assisted us in locating this foreign body in the chest wall musculature.After we had retrieved it, we employed fluoroscopy to scan the entire left subclavian area, the great vessels, the heart and the lungs and there was no evidence of retained foreign body.We then proceeded with the port-a-cath insertion.
Additional Manufacturer Narrative
One unit of damaged introducer wire was returned to vsi/teleflex for investigation.A returned product evaluation was completed.The wire was unraveled and severely damaged.Tip separation as confirmed.The tip of the wire was knotted upon itself.The damage is likely to have occurred during use when operated against resistance.Per ifu states the following warning "never advance or withdraw an intravascular device against resistance until the cause of the resistance is determined by fluoroscopy.Movement of the guidewire against resistance may result in separation of the guidewire tip, damage to the guidewire, or vessel perforation".The introducer wire is a supplier component.Supplier was notified of the complaint.And a review was requested.Supplier responded stating that the dhr (device history record) was reviewed and no non-conformances were found.No manufacturing related issue was noted.Based on the information and returned product evaluation, the most likely root cause of the issue in operational context and/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 55369
• MDR Report Key: 10736614
• Report Number: 2134812-2020-00087
• Device Sequence Number: 3346015
• Product Code: DYB
• UDI-Device Identifier: 10841156103019
• UDI-Public: (01)10841156103019
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K180913
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2020

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: 07/31/2022
• Device Model Number: 7280V
• Device Catalogue Number: 7280V
• Device Lot Number: 656625
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/29/2020
• Supplement Date Received by Manufacturer: 09/29/2020
• Initial Report FDA Received Date: 10/26/2020
• Supplement Report FDA Received Date: 01/29/2021
• 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: 49 YR
• Patient Weight: 75