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

Model Number H7493932440

Device Problem Peeled/Delaminated (1454)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/08/2018

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr: returned product consisted of a ffr comet pressure guidewire.The rfid cable was not returned.The tip, device shaft, sensor port and the modulation values were examined for damage or any irregularities.The guidewire shaft showed 2 kinks.The 1st kink was located at 126cm from the tip and the 2nd kink at 139.5cm from the tip.There also was some peeling of the coating at these locations.No other damage was noticed on the shaft.The sensor port was clear.Since the rfid cable was not returned, a test cable was used to check for modulation.The pressure wire was connected to the analysis support test bench and all applicable data was correct as designed, there was no difficulty in connecting the wire.The coefficient values could not be confirmed due to the devices rfid cable not returning with the device.The investigation conclusion is handling damage as the complaint was caused by handling of the device or portion of the device without direct patient contact.(b)(4).

Event Description

Reportable based on analysis completed on (b)(6) 2018.It was reported that a comet pressure guidewire was used in the procedure with no issue.However, returned device analysis revealed that the coating was peeling off.

• 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: 7370151
• MDR Text Key: 103542166
• Report Number: 2134265-2018-02191
• 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,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/02/2018

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: 11/11/2019
• Device Model Number: H7493932440
• Device Catalogue Number: 393244
• Device Lot Number: 21373546
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/02/2018
• Initial Date FDA Received: 03/26/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/11/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1