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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE COMET; TRANSDUCER, PRESSURE, CATHETER TIP
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BOSTON SCIENTIFIC - MAPLE GROVE COMET; TRANSDUCER, PRESSURE, CATHETER TIP Back to Search Results
Model Number H7493932430
Device Problem Break (1069)
Patient Problems Death (1802); Thrombosis (2100); Cardiac Tamponade (2226); Cardiogenic Shock (2262); Device Embedded In Tissue or Plaque (3165)
Event Date 10/24/2017
Event Type  Death  
Manufacturer Narrative
(b)(6).(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 a guidewire separation occurred, the patient underwent surgery and ultimately died.A comet guidewire was selected for use and as it was being introduced into the coronary arteries, it was detected that there was no wire pressure present on the ffr link console.It was then noted that the wire was broken.Retrieval was attempted for two hours and was unsuccessful.The patient was sent to a different hospital for surgery.The detached portion of the wire was retrieved in surgery, however, he patient died the next day.
 
Manufacturer Narrative
Updated: patient sex, weight, weight (unit), describe event or problem, device avail.For eval, returned to mfr.On, patient codes, device returned to mfr., device evaluated by mfr.,if not evaluated provide code, result codes, and conclusion codes.(b)(6).(b)(4).
 
Event Description
It was further reported that the patient presented with hypertension and a previous surgery.The target vessel was not calcified or tortuous and had 50% stenosis.Radial access was gained.The tip of the comet wire was shaped into a "j".A guide catheter was also in use.The guidewire separated 25cm from the distal end in the patient's mammary to left anterior descending artery.The wire was attempted to be removed by different snares without success.The patient died after the surgery due to cardiogenic shock.No autopsy was performed.
 
Manufacturer Narrative
Device evaluated by mfr: returned product consisted of an ffr comet wire separated in two pieces.The guidewire shaft was examined for any damage or irregularities.The shaft showed a separation at 32cm from the tip.The tip showed some bends and kinks along with stretched coils.The proximal shaft showed multiple kinks throughout its length.No other damage or irregularities were noticed.The sensor port showed evidence of blood.Functional testing of the device could not be completed due to the separation of the shaft.Because there was no evidence of any product quality deficiencies, it was considered likely that the tip damage was attributable to procedural factors.Materials testing analysis characterization (mtac) testing was performed using scanning electron microscopy.Material appears to have ductile bending overload present.A review of the procedural cine was performed.The images provided are consistent with the complaint of comet wire separation and inability to percutaneously retrieve the device fragment.The wire separation may have been caused due to sudden movement of a guiding catheter tip that was not engaged into the lima ostium.Percutaneous retrieval of the device fragment was complicated by inadequate guide catheter support and migration of the distal fragment through the vessel wall into the extravascular space.In this case death was likely due to a surgical complication since no evidence of life-threatening harm is evident in the angiographic images.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 further reported that the patient presented with hypertension and a previous surgery.The target vessel was not calcified or tortuous and had 50% stenosis.Radial access was gained.The tip of the comet wire was shaped into a "j".A guide catheter was also in use.The guidewire separated 25cm from the distal end in the patient's mammary to left anterior descending artery.The wire was attempted to be removed by different snares without success.The patient died after the surgery due to cardiogenic shock.No autopsy was performed.
 
Manufacturer Narrative
(b)(4).
 
Event Description
It was further reported that the patient presented with progressive angina, consulting repeatedly for angina.Despite treatment and the difficulties for revascularization, we are referred for a new catheterization given the frequency of symptoms (class i c of the latest (b)(4) guidelines for stable angina).Coronary angiography is performed via left radial, with the usual technique that reveals: 3-vessel disease previously revascularized surgically and percutaneously.Transient cerebral ischemia without injuries.Anterior descending (ad) with proximal chronic total occlusion.Left internal mammary artery graft to permeable distal ad with significant lesion in the distal third that also irrigates, partially the lower face, as it is a recurrent artery in the apex.Stent in proximal circumflex (cx) to first obtuse margin (om) permeable with moderate restenosis.Saphene to second om somewhat degenerated, but without significant lesions."cd" occluded in the middle third.Saphenous graft to cd occluded at the origin.In view of angiographic moderate lesions in 2 main coronary arteries, with no previous location of ischemia, treatable only ones that could be related to the patient's clinic, a functional study was performed with comet pressure guide according to usual standardized methodology, using intracoronary adenosine.The circumflex lesion is studied (not significant) and the catheter is changed for the study of anterior descending through the mammary (non bsc guide catheter).The pressures are equalized (the guide works properly) and the sensor is advanced, without detecting resistances or problems until the distal part of the anterior descending.At that point signal loss is observed from the pressure guide.Upon radiological examination, a complete fracture of the intracoronary guide was observed at the subclavian level.A fragment crosses all the anterior descending, mammary and protrudes in the subclavian artery.The other is in the catheter and outside the patient (it is completely removed).The extraction of the intravascular fragment with multiple devices and right femoral access without success and without complications was attempted for 3 hours.As the procedure progresses, with the breathing, the guide fragment that crosses the superior wall of the subclavian reaching the extravascular area is observed.With the patient asymptomatic, and completely stable, without signs or symptoms of myocardial ischemia or bleeding, he is informed of everything that happened and the procedure is considered finished.In the absence of cardiac surgery at the (b)(6) hospital in (b)(6), the cardiac surgery service corresponding to its origin (cardiac surgery of the (b)(6) hospital) is accepted.The patient accepts the case, moving to a mobile intensive care unit for the same afternoon intervention.According to the reports from (b)(6) hospital, the patient arrives stable and asymptomatic.Surgical extraction of the device is performed successfully, but in the postoperative period he suffers a hemodynamic deterioration whose cause cannot be explained accurately despite the multiple tests and procedures performed.He is discarded bleeding, with thrombosis of the breast or cardiac tamponade, the patient finally died on (b)(6) 2017 in refractory shock.
 
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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 Key7033894
MDR Text Key92088956
Report Number2134265-2017-11121
Device Sequence Number1
Product Code DXO
Combination Product (y/n)N
Reporter Country CodeES
PMA/PMN Number
NA
Number of Events Reported1
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 10/25/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/15/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/31/2018
Device Model NumberH7493932430
Device Lot Number20611110
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/30/2017
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/23/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/09/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Death; Required Intervention;
Patient Weight75
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