MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION COMET; TRANSDUCER, PRESSURE, CATHETER TIP

Model Number 8900

Device Problems Entrapment of Device (1212); Difficult to Remove (1528); Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/08/2020

Event Type  Injury  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that the device had been trapped.A percutaneous coronary intervention was being performed.When diagnostic was performed using the comet pressure guidewire in the 90% stenosed, mildly tortuous and moderately calcified right coronary artery (rca) distal to the atrioventricular branch, spasm occurred at the lesion area.And it seemed that the comet was trapped, therefore nitro was administered and it was pulled out.As it was being pulled out, the tip was stretched, so it was replaced with another comet.That device was used to complete the procedure without further issue.

• Brand Name: COMET
• Type of Device: TRANSDUCER, PRESSURE, CATHETER TIP
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 9967574
• MDR Text Key: 187888162
• Report Number: 2134265-2020-05134
• Device Sequence Number: 1
• Product Code: DXO
• UDI-Device Identifier: 08714729904403
• UDI-Public: 08714729904403
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K151610
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/03/2022
• Device Model Number: 8900
• Device Catalogue Number: 8900
• Device Lot Number: 0025155436
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/08/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/04/2020
• 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