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

Model Number H7493932430

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 01/12/2018

Event Type  Injury  

Manufacturer Narrative

Age at time of event: 18 years or older.(b)(4).

Event Description

It was reported that guidewire separation occurred.The target lesion was located in the right coronary artery (rca).While advancing a comet pressure guidewire through the vessel, more than half the wire broke into two parts with one end hanging outside the aorta, and another small part breaking off.The physician was able to retrieve the part hanging outside the aorta.The smaller part was moved to the arm and placed in a small branch when it could not be removed from the body.The physician used no force during the advancement of the wire, the wire did not prolapse during the procedure, and the tip of the wire was never trapped.The procedure was not completed due to this event.The patient is stable and doing well.No future intervention is planned to remove the device fragment.

Event Description

It was reported that guidewire separation occurred.The target lesion was located in the right coronary artery (rca).While advancing a comet pressure guidewire through the vessel, more than half the wire broke into two parts with one end hanging outside the aorta, and another small part breaking off.The physician was able to retrieve the part hanging outside the aorta.The smaller part was moved to the arm and placed in a small branch when it could not be removed from the body.The physician used no force during the advancement of the wire, the wire did not prolapse during the procedure, and the tip of the wire was never trapped.The procedure was not completed due to this event.The patient is stable and doing well.No future intervention is planned to remove the device fragment.

Manufacturer Narrative

Device evaluated by mfr: returned product consisted of a ffr comet wire separated in two pieces.The guidewire shaft was examined for any damage or irregularities.The proximal end of the shaft measured approximately 166.5cm.The distal end measured 9cm which is the total length of 175.5cm.The total length of a complete comet wire is 185cm.With only 175.5cm returning, a piece measuring approximately 9.5cm is missing and was not returned.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.The sensor port was clear of any material.Functional testing of the device could not be completed due to the separation of the shaft.Materials testing analysis characterization (mtac) testing was performed on the returned device.The two fractures submitted for analysis are not a mating pair.One location of fracture was more distal and one location was more proximal to the device tip.The distal fracture appears to have a slight bend in the slotted tube and the proximal fracture does not.Distal fracture faces exhibit a ductile shear dimple surface which is typically observed in ductile bend overload failures.The fracture occurred at the beam connectors.Profile images of the distal fracture show the directionality of the slotted tube bend which correlates to the direction of the shear dimples observed on the fracture faces.One proximal fracture face exhibits some fatigue striations and a ductile dimple surface which is typically observed in fatigue with ductile overload as the final rupture.It is difficult to see any characteristics on what should be the other fracture face.The fracture occurred at the beam connectors.Secondary or mechanical damage is observed.No micro cracks were observed.No unusual characteristics were observed.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The investigation conclusion was unable to be determined.Bsc id: (b)(4)/ tw# (b)(4).

• 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: 7260132
• MDR Text Key: 99595428
• Report Number: 2134265-2018-00571
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Reporter Country Code: SE
• 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
• Report Date: 01/16/2018

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: 08/09/2019
• Device Model Number: H7493932430
• Device Lot Number: 20989582
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/16/2018
• Initial Date FDA Received: 02/09/2018
• Supplement Dates Manufacturer Received: 02/28/2018
• Supplement Dates FDA Received: 03/26/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/11/2017
• 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