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

Model Number H7495551110

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/27/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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 approximately 172cm.The distal end measured 13cm, which equaled 185cm.The total length of a complete comet wire is 185c.There also was a kink at 38cm from the tip.The tip showed some bends and also some stretched coils.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage.The sensor port showed no evidence of blood.Functional testing of the device could not be completed due to the separation of the shaft.Because there was no evidence of any product quality deficiencies, it was considered likely that the kink, bent tip and stretched coils were attributable to procedural factors.Materials testing analysis characterization (mtac) testing was performed on the returned device.No micro-cracks were observed at the apex of slots in rows 1 thru 7 adjacent to the distal and proximal fracture ends.Some coating material was present in slots in rows 1 thru 7 adjacent to the distal and proximal fractures ends.Scanning electron microscopy (sem) images of distal and proximal beam fractures appear to show fatigue striations toward the center of fracture.Small ductile surface regions appear at center of some beam fractures for both distal and proximal ends.This suggests the possibility of reverse bending fatigue with ductile overload.Also the final rupture region appears very thin which would suggest fatigue conditions of low mean strain and/or alternating strain.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The investigation conclusion is operational context as the product meets the design & manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited.(b)(4).

Event Description

It was reported that a guidewire break occurred.Vascular access was obtained via the right radial artery.The target lesion was located in the left anterior descending artery (lad).A comet guidewire was inside a non-bsc guide catheter, the physician noticed the guidewire wasn't torquing or moving during advancement and that is when it was noted that the guidewire was fractured.The wire was removed all in one piece and then broke into two separate pieces on the table.Another of the same device was used to complete the procedure.The patient was not harmed.

• 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: 7377305
• MDR Text Key: 103688173
• Report Number: 2134265-2018-02220
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151610
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• 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: 07/15/2019
• Device Model Number: H7495551110
• Device Lot Number: 20891342
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/02/2018
• Initial Date FDA Received: 03/28/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/18/2017
• 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
• Treatment: EBU GUIDE CATHETER