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

Model Number H802228240021

Device Problems Entrapment of Device (1212); Kinked (1339)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/27/2015

Event Type  malfunction  

Event Description

Same case as mdr id: 2134265-2015-02912.It was reported that a burr became stuck on wire.The 80% stenosed target lesion was located in the moderately tortuous and severely calcified mid left anterior descending artery (lad).A 325cm rotawire was selected and advanced to the target lesion.After a 2.0mm rotalink¿ plus were used in the mid lad, a 2.25mm rotalink¿ plus were selected for used.During platforming, it was noted that the rotational speed was gradually decreased.A kink on the rotawire was suspected and so it was exchanged with another 325cm rotawire, but the same issue occurred.When the rotawire was attempted to be exchanged with another one, it was noted that the rotawire could not be removed from the burr.The rotawire remained with the burr and it was cut at the wire lumen.The procedure was completed with another of the same device.No patient complications were reported and the patient's condition was good.

Manufacturer Narrative

(b)(4).Age at time of event: 18 years or older.Device evaluated by manufacturer: the device was not returned for analysis.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).

Manufacturer Narrative

Device evaluated by manufacturer: device was returned for analysis.The visual inspection was performed and the device returned inside the catheter.The wire was removed from the catheter and the wire is kinked at approximately 4.4cm from the proximal end and fractured at approximately 172.6cm from the proximal end.The distal section of the wire was not returned approximately 157.4cm.All the outer diameter measurements are within 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: 2134265-2015-02912.It was reported that a burr became stuck on wire.The 80% stenosed target lesion was located in the moderately tortuous and severely calcified mid left anterior descending artery (lad).A 325cm rotawire was selected and advanced to the target lesion.After a 2.0mm rotalink¿ plus were used in the mid lad, a 2.25mm rotalink¿ plus were selected for used.During platforming, it was noted that the rotational speed was gradually decreased.A kink on the rotawire was suspected and so it was exchanged with another 325cm rotawire, but the same issue occurred.When the rotawire was attempted to be exchanged with another one, it was noted that the rotawire could not be removed from the burr.The rotawire remained with the burr and it was cut at the wire lumen.The procedure was completed with another of the same device.No patient complications were reported and the patient's condition was good.

• 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: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 4735047
• MDR Text Key: 5824720
• Report Number: 2134265-2015-02918
• Device Sequence Number: 1
• Product Code: MCX
• Combination Product (y/n): N
• PMA/PMN Number: P900056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: H802228240021
• Device Catalogue Number: 22824-002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/28/2015
• 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
• Treatment: GUIDE WIRE: 325CM ROTAWIRE; 2.25MM ROTALINK¿ PLUS