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

Model Number H7495551110

Device Problems Detachment Of Device Component (1104); Device Damaged Prior to Use (2284)

Patient Problem No Patient Involvement (2645)

Event Date 01/26/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that a guidewire separation occurred.A 185cm comet guidewire was selected for use.The tip was shaped during preparation and while wiping the wire off, the tip of the wire broke approximately 3cm from the tip.The device did not enter the patient's body.There were no patient complications.

Manufacturer Narrative

Updated: device evaluated by mfr., eval summary attached, method codes, results codes, conclusion codes.Device evaluated by mfr: returned product consisted of a ffr comet wire separated in two pieces.The guidewire shaft was examined for any damage or irregularities.It was noticed that the device was separated when returned.The proximal end of the shaft measured 153cm.The distal end measured 32cm which is the total length of 185cm.It was also noticed that there were 2 slight kinks on the shaft.The 1st kink was located at 8.5cm from the proximal end of the guidewire and the 2nd kink was located at 122cm from the proximal end of the guidewire.There was some coating that had also scrapped off at the 122cm location.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.The sensor port was clear of any material.Functional testing of the device could not be completed due to the separation of the shaft.Mtac testing was performed on the returned device.Coating material was present in slots in rows 1 thru 7 adjacent to the distal and proximal fracture ends.No micro-cracks were observed at apex of slots in rows 1 thru 7 adjacent to the distal and proximal fracture ends.The fracture surfaces showed the presence of dimples and discernible directional bend.This indicates the fracture mode was a ductile bend overload.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The investigation conclusion was unable to be determined.(b)(4).

Event Description

It was reported that a guidewire separation occurred.A 185cm comet guidewire was selected for use.The tip was shaped during preparation and while wiping the wire off, the tip of the wire broke approximately 3cm from the tip.The device did not enter the patient's body.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
• MDR Report Key: 7290686
• MDR Text Key: 100916371
• Report Number: 2134265-2018-01094
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• PMA/PMN Number: K151610
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/30/2018

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: 07/14/2019
• Device Model Number: H7495551110
• Device Lot Number: 20889520
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2018
• Initial Date Manufacturer Received: 01/30/2018
• Initial Date FDA Received: 02/22/2018
• Supplement Dates Manufacturer Received: 02/28/2018
• Supplement Dates FDA Received: 03/23/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1