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 05/09/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that guidewire separation occurred.Vascular access was obtained via the right radial artery.Target lesion was located in fibrous first diagonal of the proximal left anterior descending artery.Using a cls 3.5 runway guide catheter, a comet pressure guidewire was passed into the proximal lad, passing the circumflex.Prior to crossing the lesion, the physician attempted to torque the wire into a diagonal and noticed the tip was not rotating.At this stage they lost pressure.The physician withdrew the wire and realized there must have been a separation of the wire tip.The wire was separated approximately 10cm from the tip.The break looked like a clean shear.The guidewire was not bent before passing into guide.A 2mm balloon was advanced down the guide to trap the wire.This was successful and the entire wire and guide were removed from the patient.Procedure was completed with another comet pressure guidewire successfully.The patient's condition was stable.

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 169cm.The distal end measured 16cm, which equaled 185cm.The total length of a complete comet wire is 185cm.There was one kink located on the shaft.The kink was located at 19.5cm from the tip.The distal tip showed bends.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.Material testing analysis characterization was performed on the returned device.No micro-cracks were observed at the apex of slots in rows 1 through 7 adjacent to the distal and proximal fracture ends.Some coating material was present in slots in rows 1 through 7 adjacent to the distal and proximal fractures ends.Scanning electron microscopy images from one distal and one proximal beam fracture appear to show fatigue striations toward the center of fracture.Small ductile surface region appeared at center of one beam fracture on the distal end.This suggests the possibility of reverse bending fatigue with ductile overload.Some slots adjacent to both distal and proximal fracture ends show some slightly rough laser cuts near the slot apex.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 guidewire separation occurred.Vascular access was obtained via the right radial artery.Target lesion was located in fibrous first diagonal of the proximal left anterior descending artery.Using a cls 3.5 runway guide catheter, a comet pressure guidewire was passed into the proximal lad, passing the circumflex.Prior to crossing the lesion, the physician attempted to torque the wire into a diagonal and noticed the tip was not rotating.At this stage they lost pressure.The physician withdrew the wire and realized there must have been a separation of the wire tip.The wire was separated approximately 10cm from the tip.The break looked like a clean shear.The guidewire was not bent before passing into guide.A 2mm balloon was advanced down the guide to trap the wire.This was successful and the entire wire and guide were removed from the patient.Procedure was completed with another comet pressure guidewire successfully.The patient's condition was stable.

• 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: 7571509
• MDR Text Key: 110164449
• Report Number: 2134265-2018-04755
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Reporter Country Code: NZ
• 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: 05/09/2018

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: 08/15/2019
• Device Model Number: H7493932430
• Device Lot Number: 0021013923
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/09/2018
• Initial Date FDA Received: 06/05/2018
• Supplement Dates Manufacturer Received: 06/10/2018
• Supplement Dates FDA Received: 07/02/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/15/2017
• 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