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

Model Number H7493932440

Device Problem Failure to Disconnect (2541)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/22/2017

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: 18 years or older.Device evaluated by mfr: the tip, device shaft, sensor port, the rotating handle and the coefficient values were examined for damage or any irregularities.The wire was received out of the rotating handle.Functional testing of the handle was tested by inserting the wire into the handle and taking it out again.That was done multiple times without any failures.The tip showed some damage in the form of bends.The shaft showed damage in the form of two kinks.The first kink was approximately 38cm from the tip and the second kink was approximately 25.5cm from the proximal end of the device.It was also noticed that some of the coating was peeled off of the device.The sensor port was clear of any material.The pressure wire was connected and all applicable data was correct pertaining to coefficient values; however, the modulation values were nonexistent.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The root cause is not confirmed as there was no evidence of the alleged issue or any anomalies which could have contributed to the reported difficulty.(b)(4).

Event Description

Reportable based on device analysis completed on 15jun2017.It was reported that the handle could not be separated.During a fractional flow reserve (ffr) procedure, a comet pressure guidewire was selected for use in the left anterior descending artery (lad).During the procedure, the free spin handle could not be separated properly.The procedure was completed with another of the same device.No patient complications occurred.Device analysis revealed that some of the coating was peeled off of the device.

• 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: 6676441
• MDR Text Key: 78683336
• Report Number: 2134265-2017-06532
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• PMA/PMN Number: NA
• 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: 06/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2017
• Device Model Number: H7493932440
• Device Catalogue Number: 393244
• Device Lot Number: 20248203
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/15/2017
• Initial Date FDA Received: 06/29/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/10/2017
• 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