MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION COYOTE; CATHETER, PERCUTANEOUS

Model Number H74939186200610

Device Problem Fitting Problem (2183)

Patient Problem No Patient Involvement (2645)

Event Date 06/20/2018

Event Type  malfunction  

Event Description

Balloon didn't fit through a 4 fr sheath so a new balloon had to be opened to complete the procedure.Product did not have patient contact.

• Brand Name: COYOTE
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 7762173
• MDR Text Key: 116448914
• Report Number: 7762173
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: H74939186200610
• Device Lot Number: 21278961
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/11/2018
• Event Location: Hospital
• Date Report to Manufacturer: 08/08/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 24455 DA