MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (COYOL) ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM; CATHETER, CORONARY, ATHERECTOMY

Model Number UNK509

Device Problem Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluated by manufacturer: the device was returned for analysis.Visual inspection of the device revealed that the body was bent.The device body was fractured 133cm proximal of the distal tip.The broken end of the device body had excessive wear due to rotational wear.The proximal end of the rotawire was unable to be inserted into the rotablator plus device for the related complaint device, as the annulus was damaged.Dimensional inspection of the overall length could not be performed due to the fractured body.Outer diameters of distal tip, middle, and proximal section of the device were within specification.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The investigation conclusion is user / use error as there was an act or omission of an act that resulted in a different medical device response than intended by the manufacturer or expected by the user: "exercise care in handling of the guidewire during a procedure to reduce the possibility of accidental breakage, bending, kinking, or coil separation.Resulting guidewire fractures might require additional percutaneous intervention or surgery.Do not allow the individual burr run time to exceed 30 seconds as this may lead to wire fracture/tip separation that may result in perforation, dissection, embolism, myocardial infarction and in rare cases, death.The rotawire guidewire has an expected functional life of 5 minutes which is a total of individual burr run times.Do not allow the burr to remain in one location while rotating at high speeds, as this may lead to wear of the guidewire." (b)(4).

Event Description

Same case as mdr id: 2134265-2018-01690.Reportable based on device analysis completed on 17-feb-2018.It was reported that the burr would not load onto the rotawire.A 1.25mm rotalink¿ plus and a rotawire¿ were selected for use in a coronarography room.During the procedure, it was noted that the rotaburr would not load onto the rotawire.No patient complications were reported.However, device analysis revealed that the rotawire was fractured.

• Brand Name: ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC - COSTA RICA (COYOL); 2546 first street; propark free zone; alajuela ; CS
• Manufacturer (Section G): BOSTON SCIENTIFIC - COSTA RICA (COYOL); 2546 first street; propark free zone; alajuela ; CS
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 7338331
• MDR Text Key: 102455778
• Report Number: 2134265-2018-02465
• Device Sequence Number: 1
• Product Code: MCX
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P900056
• 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: 02/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNK509
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/17/2018
• Initial Date FDA Received: 03/14/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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