MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EXPO GUIDE CATHETER; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number	7840
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	07/12/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient experienced a dissection.The target lesion was located in left heart.A 5f expo guide catheter was selected for percutaneous coronary intervention.During the procedure, imaging was performed and everything looked fine.The 5f expo guide catheter was used.When the second set of imaging was completed after using this device, a dissection was observed.Intervention was performed with balloons and stents.The procedure was completed with medical intervention.The case was completed and the patient was flown to another hospital.No further patient complications were reported.
Additional Manufacturer Narrative
Adverse event/product problem was corrected from adverse event and product problem to adverse event.
Event or Problem Description
It was reported that the patient experienced a dissection.The target lesion was located in left heart.A 5f expo guide catheter was selected for percutaneous coronary intervention.During the procedure, imaging was performed and everything looked fine.The 5f expo guide catheter was used.When the second set of imaging was completed after using this device, a dissection was observed.Intervention was performed with balloons and stents.The procedure was completed with medical intervention.The case was completed and the patient was flown to another hospital.No further patient complications were reported.

• Brand Name: EXPO GUIDE CATHETER
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8901390
• Report Number: 2134265-2019-09811
• Device Sequence Number: 16206514
• Product Code: DQO
• UDI-Device Identifier: 08714729187813
• UDI-Public: 08714729187813
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K120495
• 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): 08/16/2019

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: 05/14/2021
• Device Model Number: 7840
• Device Catalogue Number: 7840
• Device Lot Number: 0060185733
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/29/2019
• Supplement Date Received by Manufacturer: 07/29/2019
• Initial Report FDA Received Date: 08/16/2019
• Supplement Report FDA Received Date: 08/16/2019
• 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