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

Model Number H7493932430

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/20/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that a wire break occurred.The target lesion was located in the extremely tortuous circumflex (cx) artery.The physician noted difficulty getting the comet wire to the distal cx lesion.When pulling back the comet wire, the 15cm distal part of comet broke and was hanging partly in guide catheter and artery.Using trapping technic the physician retrieved the 15cm broken wire.The procedure was completed with a different device.No patient complications were reported.

Manufacturer Narrative

Updated: device evaluated by mfr.Returned product consisted of a ffr comet wire.The device was separated; however, the separated piece was not returned.The shaft was separated approximately 15cm from the tip.The separated portion of the device was retrieved from the patient but was not returned for evaluation.The fracture face shows evidence of fatigue due to the crack propagation lines moving towards the middle of the fracture surface.Some fracture faces show evidence of a small dimple region.This would indicate that reverse bending occurred under a cyclic stress, resulting in failure in the middle with ductile overload.Secondary damage is also present on all fracture surfaces.No other damage or irregularities were noticed.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 a wire break occurred.The target lesion was located in the extremely tortuous circumflex (cx) artery.The physician noted difficulty getting the comet wire to the distal cx lesion.When pulling back the comet wire, the 15cm distal part of comet broke and was hanging partly in guide catheter and artery.Using trapping technic the physician retrieved the 15cm broken wire.The procedure was completed with a different device.No patient complications were reported.

• 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: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 5896060
• MDR Text Key: 52735504
• Report Number: 2134265-2016-07453
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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: 07/27/2016

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: 02/28/2017
• Device Model Number: H7493932430
• Device Lot Number: 19250936
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/27/2016
• Initial Date FDA Received: 08/23/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/25/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/14/2016
• 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): Required Intervention