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

Model Number UNK509

Device Problem Delivered as Unsterile Product (1421)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: 18 years or older.Device evaluated by manufacturer: the complaint device was not received for analysis.The batch number is unknown and the manufacturing records for the complaint device could not be reviewed.The most probable root cause was unable to be determined.(b)(4).

Event Description

It was reported that the rotawire was contaminated.A rotawire was selected for use.During preparation, the product was noted to be contaminated while it was placed on the sterile field.The product was removed.The procedure was completed with a different device.There were no patient complications.

• 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: 6165684
• MDR Text Key: 62376711
• Report Number: 2134265-2016-11267
• Device Sequence Number: 1
• Product Code: MCX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P900056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/18/2016

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?: No
• Initial Date Manufacturer Received: 11/18/2016
• Initial Date FDA Received: 12/12/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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