MAUDE Adverse Event Report: VASCULAR SOLUTIONS, INC SPECTRE GUIDEWIRE

Model Number	7386
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Pericardial Effusion (3271)
Date of Event	02/21/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A manufacturing record review was completed and zero nonconformances were found.There was no returned product to complete an evaluation on.Based on the event details it is most likely that the tortuosity of the vessel the device was being used in caused the damage.
Event or Problem Description
Physician wired a diagonal vessel that was 100 percent occluded isr without any difficulty or resistance.Stent was delivered over wire with success.During removal of wire distal portion of wire in diagonal fractured and was left in the vessel.Patient experienced massive effusion thus getting a pericardiocentesis.The plan was to leave the fractured wire in place.The patient received a pericardiocentesis with 190 ml of blood removed.Ct surgery was consulted and was going to monitor the patient before further surgical intervention or pericardial window.The portion of the wire that was removed from the body was given to the director of the lab for facility risk analysis.Follow-up procedure was/were performed s/p pericardiocentesis.It was reported the guidewire was retained in the patient.

• Brand Name: SPECTRE GUIDEWIRE
• Common Device Name: GUIDEWIRE
• Manufacturer (Section D): VASCULAR SOLUTIONS, INC; 6464 sycamore court north; minneapolis MN 55369
• MDR Report Key: 7363982
• Report Number: 2134812-2018-00014
• Device Sequence Number: 11066732
• Product Code: DQX
• UDI-Device Identifier: M20673861
• UDI-Public: M20673861
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K163444
• 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): 02/21/2018

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: 10/04/2019
• Device Model Number: 7386
• Device Lot Number: 614283
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/21/2018
• Initial Report FDA Received Date: 03/22/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR
• Patient Weight: 63