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

Model Number H802228240021

Device Problem Fracture (1260)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/01/2015

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: 18 years or older.(b)(4).Device evaluated by mfr: the complaint device was not received for analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause has been determined to be use/user error as the direction for use states: "ensure that the free lumen rotational speed of the burr does not exceed 180,000 rpm for 1.25 mm to 2.0 mm burrs and 160,000 rpm for the 2.15 mm and larger burr sizes." (b)(4).

Event Description

Same case as mdr id 2134265-2015-09159.It was reported that a rotawire fracture issue occurred.A 1.50mm rotalink plus and a 325cm rotawire were selected for treatment.During preparation, outside the patient's body, the rotation speed was increased to 200,000rpm; however, it was noted that the rotawire was torn.The procedure was completed with another of the same rotawire.There were no patient complications reported and the patient's condition was good.

Manufacturer Narrative

Device returned to mfr: unit returned in a generic plastic bag.The guidewire was returned inside the rotablator catheter.A visual inspection observed a kink at 54cm approximately from the proximal end.Furthermore, the guidewire is broken at 194.3cm approximately from the proximal end.Wear reduction marks were noted on the fracture point.The most distal part of the wire was not returned.The guidewire overall length was out of specification.The outer diameter of the spring tip could not be taken due to the condition of the device.All the outer diameter (od) measurements taken are within specifications.The batch number is unknown and the manufacturing records for the complaint device could not be reviewed.The most probable root cause has been determined to be use/user error as the direction for use states: "ensure that the free lumen rotational speed of the burr does not exceed 180,000 rpm for 1.25 mm to 2.0 mm burrs and 160,000 rpm for the 2.15 mm and larger burr sizes." (b)(4).

Event Description

Same case as mdr id 2134265-2015-09159.It was reported that a rotawire fracture issue occurred.A 1.50mm rotalink¿ plus and a 325cm rotawire were selected for treatment.During preparation, outside the patient's body, the rotation speed was increased to 200,000rpm; however, it was noted that the rotawire was torn.The procedure was completed with another of the same rotawire.There were no patient complications 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: 5324484
• MDR Text Key: 34999082
• Report Number: 2134265-2015-09161
• 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: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/01/2015

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: H802228240021
• Device Catalogue Number: 22824-002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/01/2015
• Initial Date FDA Received: 12/23/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/14/2016
• 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