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 03/09/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that a guidewire break occurred.Vascular access was obtained via the right radial artery.The moderate to severely stenosed,target lesion was located in the severely calcified and very tortuous right coronary artery (rca).A comet guidewire passed down the proximal rca, but would not pass distally despite a buddy wire.With the manipulation of the pressure wire, the wire separated 30cm from the tip.The distal portion of the wire remained in the rca and a portion of the wire remained in the catheter.A gooseneck snare was used in an attempt to snare the wire but failed.A 2.5mm non-bsc balloon was passed distal to the wire in the catheter hence jailing the pressure wire in the catheter.The catheter and wires were withdrawn.There were no patient complications.

Manufacturer Narrative

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 approximately 161.5cm.The distal end measured 23.5cm, which equals 185cm.The total length of a complete comet wire is 185cm.There were 2 kinks also located on the shaft.The 1st kink was located at 13cm from the proximal end of the device.The 2nd kink was located at the seam weld 38cm from the tip.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.Materials testing analysis characterization (mtac) testing was performed on the returned device.Micro-cracks were observed at the apex of slots in rows 2 and 6 adjacent to the distal fracture end.Coating material was present in some slots in rows 1 thru 7 adjacent to the distal fracture end and in all slots in rows 1 thru 7 adjacent to the proximal end.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 thin which would suggest fatigue conditions of low mean strain and/or alternating strain (i.E.The wire was spun around a curve that was not a very sharp turn.) 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 moderate to severely stenosed,target lesion was located in the severely calcified and very tortuous right coronary artery (rca).A comet guidewire passed down the proximal rca, but would not pass distally despite a buddy wire.With the manipulation of the pressure wire, the wire separated 30cm from the tip.The distal portion of the wire remained in the rca and a portion of the wire remained in the catheter.A gooseneck snare was used in an attempt to snare the wire but failed.A 2.5mm non-bsc balloon was passed distal to the wire in the catheter hence jailing the pressure wire in the catheter.The catheter and wires were withdrawn.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
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 7397904
• MDR Text Key: 104402993
• Report Number: 2134265-2018-02713
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Reporter Country Code: AU
• 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,Followup
• Report Date: 03/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/21/2019
• Device Model Number: H7493932430
• Device Lot Number: 21032066
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/14/2018
• Initial Date FDA Received: 04/04/2018
• Supplement Dates Manufacturer Received: 04/14/2018
• Supplement Dates FDA Received: 05/09/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/23/2017
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 82 YR
• Patient Weight: 75