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

Model Number H7493932430

Device Problems Break (1069); Difficult to Remove (1528)

Patient Problem Intimal Dissection (1333)

Event Date 10/21/2017

Event Type  Injury  

Manufacturer Narrative

(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 removal difficulty, tip break, and vessel dissection occurred.Vascular access was obtained via right radial approach.Activated clotting time guided heparin was administrated.The target lesion was located at the mid left anterior descending artery (mid lad).A comet pressure guidewire was advanced to the distal lad and performed fractionated flow reserve (ffr) measurement with two minutes of adenosine infusion at 140 mcg/kg/min.The lad lesion was functionally significant.Then the comet wire was used to assess the lesion at the diagonal branch which was also significant.The comet wire was kept in the diagonal vessel.A non-bsc guidewire was placed in the lad.After pre-dilation, a 2.75x28mm synergy stent was implanted across the origin of the diagonal branch, thus jailing the guidewire.Proximal optimization technique (pot) was used on the proximal portion of the stent.Then the diagonal branch was rewired with a new non-bsc guidewire.While attempting to remove the comet wire, resistance was felt after the wire came out of the stent under fluoroscopy guidance, followed by immediate give way.Angiography confirmed that the wire detached between the radio opaque and the rest of the wire.About 5cm of the wire was retained inside the proximal lad.Attempts to retrieve it were unsuccessful.There was evidence of dissection at the ostial lad, which was probably caused by the torn tip of the wire poking around.A non-bsc guide extension catheter was used after withdrawing the wire.A semi-compliant balloon was advanced to the proximal part of the stent with difficulty.Series of dilations were performed followed by stenting of the left main coronary artery and lad with a 3.0x28mm promus stent, trapping the broken tip between the stent and the vessel wall.Post-dilation was performed with a 4.0 nc balloon catheter at high pressure.The patient was advised for 12 months dual antiplatelet therapy.

• 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: 7041150
• MDR Text Key: 92331250
• Report Number: 2134265-2017-11029
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Reporter Country Code: GB
• 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
• Report Date: 10/23/2017

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: 02/18/2018
• Device Model Number: H7493932430
• Device Lot Number: 20688515
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/23/2017
• Initial Date FDA Received: 11/17/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/31/2017
• 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
• Treatment: 6 FR SYSTEM/ EBU 3.5 GUIDE CATHETER; SION BLUE GUIDEWIRE
• Patient Outcome(s): Required Intervention