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

Model Number H7493932440

Device Problem Break (1069)

Patient Problems No Consequences Or Impact To Patient (2199); Device Embedded In Tissue or Plaque (3165)

Event Date 06/08/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that wire breakage occurred.The 50% stenosed lesion was located in the moderately tortuous mid right coronary artery (rca).A comet pressure was selected and shaping was performed.Ffr was performed in the lesion with the pressure wire.When the device was advanced to the peripheral, pd pressure was not displayed.Detachment of approximately 12 cm of the comet wire occurred.The procedure with comet was performed with a younger physician and when the separation occurred, another physician attempted bailout.The physician attempted to retrieve the fragment via snare however, there was difficulty crossing and the retrieval attempt was unsuccessful.A 6fr guide catheter was used.There was difficulty engaging the guide catheter due to the vessel anatomy.The guide catheter disengaged during bailout attempts.The distal portion of the separated part was trapped in a small vessel and the proximal portion of the separated part did not remain in the guide catheter.The patient was sedated halfway during the procedure due to the prolonged procedure time.The total procedure time was 6 hr 30min.Retrieval attempts were discontinued and the patient was sent to the icu.The next day, surgery was performed to remove the wire fragment.Surgery then continued for bypass surgery.

Manufacturer Narrative

(b)(4).

Event Description

It was further reported that vascular access was obtained via a radial approach.No resistance was noted prior to the separation.The patient's current status is stable.

Manufacturer Narrative

Device evaluated by mfr: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 171cm.The length of the tip portion returned was 14cm.No other damage or irregularities were noticed.The sensor port showed traces of blood.Functional testing of the device could not be completed due to the separation of the shaft.Sem analysis revealed that some micro cracks were observed in the slots 2 rows adjacent to the distal fracture.The beam fracture surfaces for both the distal and proximal ends show fatigue striations toward the center of fracture.Some of these fracture surfaces also show ductile surface at the fracture center.This suggests the possibility of reverse bending with fatigue overload.The fracture occurred approximately 14 cm from the distal tip.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 wire breakage occurred.The 50% stenosed lesion was located in the moderately tortuous mid right coronary artery (rca).A comet pressure was selected and shaping was performed.Ffr was performed in the lesion with the pressure wire.When the device was advanced to the peripheral, pd pressure was not displayed.Detachment of approximately 12 cm of the comet wire occurred.The procedure with comet was performed with a younger physician and when the separation occurred, another physician attempted bailout.The physician attempted to retrieve the fragment via snare however, there was difficulty crossing and the retrieval attempt was unsuccessful.A 6fr guide catheter was used.There was difficulty engaging the guide catheter due to the vessel anatomy.The guide catheter disengaged during bailout attempts.The distal portion of the separated part was trapped in a small vessel and the proximal portion of the separated part did not remain in the guide catheter.The patient was sedated halfway during the procedure due to the prolonged procedure time.The total procedure time was 6 hr 30min.Retrieval attempts were discontinued and the patient was sent to the icu.The next day, surgery was performed to remove the wire fragment.Surgery then continued for bypass surgery.

Manufacturer Narrative

(b)(4).

Event Description

It was further reported that the fragmented tip was seen in a vessel.

Manufacturer Narrative

Describe event or problem :updated and corrected.(b)(4).

Event Description

It was further reported that the lesion was 75% stenosed, not 50% as previously reported.The lesion was in the proximal to mid right coronary artery (rca), not the mid rca as previously reported.The comet wire was advanced to the coronary artery, 4 pd.The distal part of the coment went into a small branch; therefore, the comet wire was removed outside the body.The shape of the distal part of the comet was changed and the comet was inserted again into the coronary artery.During handling of the comet, manipulation at the proximal part of the comet was not delivered to the distal part of the comet which was located in coronary artery, therefore, the comet was removed outside the body and it was confirmed that the distal part of the comet got detached.Angiography was performed and it was noted that the detached part of the comet was left in the coronary artery.It was considered that the detached part of the comet remained in the valsalva sinus from the procedure process and angiography result.Transcatheter removal of the detached part of the comet was attempted.It was difficult to catch the detached part of the comet by using snare, and another attempt by wire twist was performed but it was unsuccessful.It was attempted to change the placement of the distal wire by using the resistance of an inflated balloon within a stent, but it was unsuccessful.Keeping a guide catheter engagement coaxially was difficult due to the anomalous of the origin of right coronary artery (right coronary was originated from front).And another approach from the femoral artery was obtained.By using double guide system, removal for the detached part of the comet with a snare catheter was attempted, but it was hard to remove the detached part of the comet.By using a multifunction catheter, guidewire, guideliner and etc, it was attempted to change the wire position but it was difficult to do it.Coronary angiography was performed, it was suspected that the detached part did not remain in the valsalva sinus, and ivus was performed.With the analysis of ivus image and perspective image, distal end of the detached part was located in a small side branch at proximal to the 4pd, and the proximal of the detached part was located in a side branch at proximal rca.It was considered that transcatheter removal of the detached part was not only difficult but it could also have a risk to cause coronary perforation, then it was decided to close the procedure.Thoracotomy was performed to remove the detached part of the comet from 4pd.

• 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: 6660508
• MDR Text Key: 78176852
• Report Number: 2134265-2017-06313
• 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,Followup,Followup
• Report Date: 06/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2017
• Device Model Number: H7493932440
• Device Catalogue Number: 393244
• Device Lot Number: 20358636
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/09/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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