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

Model Number H7493932440

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Intimal Dissection (1333)

Event Date 05/08/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the guide wire tip detached and a dissection occurred.Vascular access was obtained via the right radial artery.Fractional flow reserve (ffr) was performed in the 50% stenosis with a 60 mm long lesion in the left circumflex artery (lcx) entering from a severely tortuous and steep left main trunk artery (lmt) using a comet¿ pressure guidewire.The insertion of comet to the lcx peripheral was attempted using a non-bsc 4f angiographic catheter and non-bsc introducer sheath but it was difficult to insert due to severe vessel tortuosity.The physician attempted to manipulate the comet to advance by applying torque about 3 turns each on the left and right.During manipulation the waveform on the ilab monitor disappeared, so the physician decided to remove the comet from the patient's body.After the comet was removed, it was confirmed by angiography that the tip detached about 6 cm from the tip.The detached portion of the comet remained in the area near proximal lcx.A 6f mach1 cls3.5 and non-bsc guidewire was inserted to attempt to retrieve the comet but was unsuccessful.The detached tip dislodged from the lcx proximal into the left anterior descending artery (lad).The physician used a non-bsc 4 mm diameter snare to successfully retrieve the detached tip.During the retrieval of the detached tip of the comet penetrated the lad causing a dissection.A non-bsc stent was implanted to treat the dissection.No further patient complications were reported.The procedure was not completed and the patient status is fine.

Manufacturer Narrative

Device evaluated by manufacturer ¿ returned product consisted of a ffr comet wire separated into 2 segments.The proximal shaft and the tip were returned.The shaft was separated in 1 place.The total proximal shaft length that was returned was approximately 179cm.The length of the tip portion returned was approximately 5cm.This means that there is a 1cm piece of the guidewire missing.The customer was contacted to verify if all pieces were accounted for when shipped, their return response was yes with a photo supporting their statement.Further inspection showed a kink on the shaft approximately 89.5cm from the separated distal end.No other damage or irregularities were noticed.The sensor port was clear of any material.Functional testing of the device could not be completed due to the separation damage of the shaft.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is operational context as device performance was limited due to anatomical procedural factors.(b)(4).

Event Description

It was reported that the guide wire tip detached and a dissection occurred.Vascular access was obtained via the right radial artery.Fractional flow reserve (ffr) was performed in the 50% stenosis with a 60 mm long lesion in the left circumflex artery (lcx) entering from a severely tortuous and steep left main trunk artery (lmt) using a comet¿ pressure guidewire.The insertion of comet to the lcx peripheral was attempted using a non-bsc 4f angiographic catheter and non-bsc introducer sheath but it was difficult to insert due to severe vessel tortuosity.The physician attempted to manipulate the comet to advance by applying torque about 3 turns each on the left and right.During manipulation the waveform on the ilab monitor disappeared, so the physician decided to remove the comet from the patient's body.After the comet was removed, it was confirmed by angiography that the tip detached about 6cm from the tip.The detached portion of the comet remained in the area near proximal lcx.A 6f mach1 cls3.5 and non-bsc guidewire was inserted to attempt to retrieve the comet but was unsuccessful.The detached tip dislodged from the lcx proximal into the left anterior descending artery (lad).The physician used a non-bsc 4mm diameter snare to successfully retrieve the detached tip.During the retrieval of the detached tip of the comet penetrated the lad causing a dissection.A non-bsc stent was implanted to treat the dissection.No further patient complications were reported.The procedure was not completed and the patient status is fine.

Manufacturer Narrative

Device evaluated by mfr: additional information: further scanning electron microscopy (sem) revealed that the beam width measurements from the fracture surfaces and the two rows adjacent to the proximal and distal fracture ends appear normal.No micro cracks were observed at any measured beam locations.The fractured distal end gives some indication of a ductile overload failure.Some fatigue striations also appeared present on the fractured proximal end.Since approximately 1 cm is the wire sample missing between the distal and proximal fractured ends, it was not possible to determine a more definite failure mode for this device.Bsc id # (b)(4) / tw# (b)(4).

Event Description

It was reported that the guide wire tip detached and a dissection occurred.Vascular access was obtained via the right radial artery.Fractional flow reserve (ffr) was performed in the 50% stenosis with a 60 mm long lesion in the left circumflex artery (lcx) entering from a severely tortuous and steep left main trunk artery (lmt) using a comet¿ pressure guidewire.The insertion of comet to the lcx peripheral was attempted using a non-bsc 4f angiographic catheter and non-bsc introducer sheath but it was difficult to insert due to severe vessel tortuosity.The physician attempted to manipulate the comet to advance by applying torque about 3 turns each on the left and right.During manipulation the waveform on the ilab monitor disappeared, so the physician decided to remove the comet from the patient's body.After the comet was removed, it was confirmed by angiography that the tip detached about 6cm from the tip.The detached portion of the comet remained in the area near proximal lcx.A 6f mach1 cls3.5 and non-bsc guidewire was inserted to attempt to retrieve the comet but was unsuccessful.The detached tip dislodged from the lcx proximal into the left anterior descending artery (lad).The physician used a non-bsc 4mm diameter snare to successfully retrieve the detached tip.During the retrieval of the detached tip of the comet penetrated the lad causing a dissection.A non-bsc stent was implanted to treat the dissection.No further patient complications were reported.The procedure was not completed and the patient status is fine.

• 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: 6581079
• MDR Text Key: 75606014
• Report Number: 2134265-2017-05065
• 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,distri
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/08/2017

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: 10/31/2017
• Device Model Number: H7493932440
• Device Catalogue Number: 393244
• Device Lot Number: 20248202
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/08/2017
• Initial Date FDA Received: 05/22/2017
• Supplement Dates Manufacturer Received: Not provided; 07/17/2017
• Supplement Dates FDA Received: 06/26/2017; 08/08/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/15/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Weight: 48