MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE COMET; TRANSDUCER, PRESSURE, CATHETER TIP

Model Number H7495551110

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Intimal Dissection (1333)

Event Date 11/16/2017

Event Type  Injury  

Manufacturer Narrative

Device evaluated by mfr: it is indicated that the device will not be returned for evaluation.If there is further relevant information obtained, a supplemental medwatch will be filed.(b)(4).

Event Description

It was reported that vessel dissection occurred.The target lesion was located in the moderate tortuosity and calcified proximal left anterior descending artery (lad).A 185cm comet pressure guidewire was advanced to the target lesion.After delivering the wire across the lesion, there was a dissection of the mid lad.The dissection was treated by stenting the lad.In stenting the lad, there was compromised flow into a diagonal off the lad in which they attempted to balloon it open.The procedure ended fine, and there were no patient complications.

• Brand Name: COMET
• Type of Device: TRANSDUCER, PRESSURE, CATHETER TIP
• Manufacturer (Section D): BOSTON SCIENTIFIC - MAPLE GROVE; one scimed place; maple grove MN 55311
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 7109465
• MDR Text Key: 94550912
• Report Number: 2134265-2017-12180
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151610
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/22/2017

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?: No
• Device Operator: Health Professional
• Device Model Number: H7495551110
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/22/2017
• Initial Date FDA Received: 12/12/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention