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

Model Number H7493932430

Device Problem Break (1069)

Patient Problems Intimal Dissection (1333); Death (1802); Low Blood Pressure/ Hypotension (1914); Device Embedded In Tissue or Plaque (3165)

Event Date 12/07/2016

Event Type  Death  

Manufacturer Narrative

Patient identifier:(b)(6).Complainant name:(b)(6) hospital.(b)(4).Device evaluated by mfr: the device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).

Event Description

It was reported that wire breakage, vessel dissection and patient death occurred.Vascular access was obtained via right radial and femoral approaches.The 50% stenosed target lesion with ulcerative plaque was located in the ostial left anterior descending (lad) artery.Ffr at baseline was 0.95 and after adenosine 0.85.The left circumflex was noted to be chronically totally occluded (cto).The right coronary artery (rca) had a patent stent in the mid rca and a cto of the distal rca.A comet pressure wire was advanced to the rca for ffr through a jr4 6f catheter.The wire developed a fracture shortly after wiring.A variety of techniques were performed to try and remove the remaining device fragment; including twisting wire, the use of a 4mm snare, balloon trapping and pullback with a 3.0x15 and 3.0x25 non-bsc balloon catheters."the rendezvous technique" was performed with the guide catheter, but none of these techniques worked.Final angiographic images revealed a small dissection at the proximal rca.The patient was sent to emergency coronary artery bypass graft surgery.The patient died on the following day.

Manufacturer Narrative

Death date, describe event or problem, other relevant history, patient codes, device available for eval, returned to mfr on, device returned to mfr, device evaluated by mfr, if no evaluated provide code, result codes, conclusion codes: updated.(b)(4).

Event Description

It was further reported that the patient had a history of pct at the rca many years ago.The patient was lost to follow up and missed medications for a few years before returning batch due a history of heart failure or acs.The comet wire was being used to measure ffr at the mid lad and wiring the lesion at the distal rca.There was no abnormal patient anatomy that caused bending/kinking of the comet wire.A few minutes after attempting to cross the cto at the distal rca, the physician wanted to pull back the wire, and found that the tip of the wire was stuck at the same place wile the shaft moved backward.The initial separation was located about 10+cm from the tip, right at the ostium of the rca.The previously reported twisted wire technique was conducted initially with 2 wires prior to the snare attempt and then again with 3 wires following the snare attempt.The techniques "absolutely" failed in managing the lost wire.The dissection occurred almost at the end of the procedure, due to balloon dilatation and pulling back from the mid rca through the ostium.The pci was almost 3 hours in length and the patient's hemodynamic conditions were stable throughout.Following the pci, emergent surgical consultation was made and the patient was moved to ccu awaiting surgery.During the night, the patient developed hypotension and restlessness.Iv vasopressors were administered to maintain blood pressure.The emergent cabg was started approximately 8.5 hours after the end of the pci.The separated fragment was easily removed from the rca using atherectomy technique.Clot was found in the rca and was successfully removed.The cabg procedure proceeded smoothly, but the patient's hemodynamic condition deteriorated throughout the procedure and made it impossible for weaning off the heart - lung machine.After "long" waiting fro recovery and full range of resuscitation, the patient was declared dead on the operating table, approximately 11 hours after the cabg began.The cause of death was difficult to clarify, but one possible explanation was severe myocardial dysfunction due to ischemic injury.

Manufacturer Narrative

Device evaluated by mfr, eval summary attached, method codes, result codes, conclusion codes: updated device evaluated by mfr: the returned product consisted of a ffr comet wire.The shaft showed a bend approximately 18 cm from the end of the proximal separation.The tip was separated from the device.Approximately 8 cm of the tip was missing and not returned with the device.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.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 further reported that the patient had a history of pct at the rca many years ago.The patient was lost to follow up and missed medications for a few years before returning batch due a history of heart failure or acs.The comet wire was being used to measure ffr at the mid lad and wiring the lesion at the distal rca.There was no abnormal patient anatomy that caused bending/kinking of the comet wire.A few minutes after attempting to cross the cto at the distal rca, the physician wanted to pull back the wire, and found that the tip of the wire was stuck at the same place wile the shaft moved backward.The initial separation was located about 10+cm from the tip, right at the ostium of the rca.The previously reported twisted wire technique was conducted initially with 2 wires prior to the snare attempt and then again with 3 wires following the snare attempt.The techniques "absolutely" failed in managing the lost wire.The dissection occurred almost at the end of the procedure, due to balloon dilatation and pulling back from the mid rca through the ostium.The pci was almost 3 hours in length and the patient's hemodynamic conditions were stable throughout.Following the pci, emergent surgical consultation was made and the patient was moved to ccu awaiting surgery.During the night, the patient developed hypotension and restlessness.Iv vasopressors were administered to maintain blood pressure.The emergent cabg was started approximately 8.5 hours after the end of the pci.The separated fragment was easily removed from the rca using atherectomy technique.Clot was found in the rca and was successfully removed.The cabg procedure proceeded smoothly, but the patient's hemodynamic condition deteriorated throughout the procedure and made it impossible for weaning off the heart - lung machine.After "long" waiting fro recovery and full range of resuscitation, the patient was declared dead on the operating table, approximately 11 hours after the cabg began.The cause of death was difficult to clarify, but one possible explanation was severe myocardial dysfunction due to ischemic injury.

Manufacturer Narrative

Mtac report showed that the most likely result of the separation was bending fatigue with ductile overload.(b)(4).

Event Description

It was further reported that the patient had a history of pct at the rca many years ago.The patient was lost to follow up and missed medications for a few years before returning batch due a history of heart failure or acs.The comet wire was being used to measure ffr at the mid lad and wiring the lesion at the distal rca.There was no abnormal patient anatomy that caused bending/kinking of the comet wire.A few minutes after attempting to cross the cto at the distal rca, the physician wanted to pull back the wire, and found that the tip of the wire was stuck at the same place wile the shaft moved backward.The initial separation was located about 10+cm from the tip, right at the ostium of the rca.The previously reported twisted wire technique was conducted initially with 2 wires prior to the snare attempt and then again with 3 wires following the snare attempt.The techniques "absolutely" failed in managing the lost wire.The dissection occurred almost at the end of the procedure, due to balloon dilatation and pulling back from the mid rca through the ostium.The pci was almost 3 hours in length and the patient's hemodynamic conditions were stable throughout.Following the pci, emergent surgical consultation was made and the patient was moved to ccu awaiting surgery.During the night, the patient developed hypotension and restlessness.Iv vasopressors were administered to maintain blood pressure.The emergent cabg was started approximately 8.5 hours after the end of the pci.The separated fragment was easily removed from the rca using atherectomy technique.Clot was found in the rca and was successfully removed.The cabg procedure proceeded smoothly, but the patient's hemodynamic condition deteriorated throughout the procedure and made it impossible for weaning off the heart - lung machine.After "long" waiting fro recovery and full range of resuscitation, the patient was declared dead on the operating table, approximately 11 hours after the cabg began.The cause of death was difficult to clarify, but one possible explanation was severe myocardial dysfunction due to ischemic injury.

• 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: 6197870
• MDR Text Key: 63066077
• Report Number: 2134265-2016-12007
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Reporter Country Code: TH
• 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,Followup,Followup
• Report Date: 12/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2017
• Device Model Number: H7493932430
• Device Lot Number: 0019574538
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/11/2016
• 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): Death; Required Intervention
• Patient Age: 71 YR