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

Model Number UNK509

Device Problems Degraded (1153); Material Discolored (1170)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/10/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Same case as mdr id: 2134265-2016-08108.A rota wire was received with mdr id# 2134265-2016-08108 with no reported issues.However, upon review of this device, a discoloration with wear marks and a missing material was noted.

Manufacturer Narrative

Device evaluated by mfr: the device was returned for analysis.A visual inspection of the device revealed no discoloration in any section of the wire.The device has a body kinked in several sections in the middle of the device, also it has the spring tip kinked.The dimension of the wire was taken and met the specifications.The batch number is unknown and the manufacturing records for the complaint device could not be reviewed.The most probable root cause is considered handling damage as the event occurred without direct patient contact.(b)(4).

Event Description

Same case as mdr id: 2134265-2016-08108.A rota wire was received with mdr id# 2134265-2016-08108 with no reported issues.However, upon review of this device, a discoloration with wear marks and a missing material was noted.

Manufacturer Narrative

The rotational wear was damaged and discoloration was found in the kinked section of the wire.(b)(4).

Event Description

Same case as mdr id: 2134265-2016-08108.A rota wire was received with mdr id# 2134265-2016-08108 with no reported issues.However, upon review of this device, a discoloration with wear marks and a missing material was noted.

• 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: 6026548
• MDR Text Key: 57321371
• Report Number: 2134265-2016-09127
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 09/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2016
• 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: 09/26/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/12/2017
• 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