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

Model Number H7493932430

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/03/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Device evaluated by manufacturer: the device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).

Event Description

It was reported that a guidewire fractured.During a percutaneous transluminal coronary angioplasty (ptca) procedure, a comet pressure guidewire was used to perform a fractional flow reserve evaluation in the right coronary artery.Then, the same wire was used to evaluate the binary stenosis in the left anterior descending artery (lad).The wire was advanced to the lad with no resistance.The physician decided to withdraw the wire a little bit because the tip was not in the main vessel but in a small branch.When he tried to withdraw the wire the tip didn't follow the proximal part of the wire.A trapping balloon technique was used to successfully remove the wire and the tip.The wire was broken in four different parts.Intravascular ultrasound (ivus) was used to confirm the wire removal was successful.The procedure was completed with a different device.There were no patient complications and the patient status is stable.

• 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: 6742303
• MDR Text Key: 80968727
• Report Number: 2134265-2017-07191
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2017
• Device Model Number: H7493932430
• Device Lot Number: 20462350
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/03/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/30/2017
• 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