MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (HEREDIA) PERIPHERAL ROTAWIRE¿ AND WIRECLIP® TORQUER; CATHETER, PERIPHERAL, ATHERECTOMY

Model Number M0011373321

Device Problems Fracture (1260); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/28/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Same case as mdr id: 2134265-2017-13374 and 2134265-2018-00424.It was reported that foreign matter was observed on the rotawire and a rotawire fracture occurred.The target lesion was located in the anterior tibial artery of the right lower leg.A peripheral rotawire¿ and a peripheral rotalink® plus were selected for use.There were two rotawires that were pulled out from its hoop and white debris was observed at the proximal end.Subsequently, the second rotawire was used during platforming.When the physician loaded the rotaburr onto the rotawire, it was noted that the wire snapped in half.The rotawire was exchanged with another of the same device and the rotaburr was loaded onto it.However, the burr was unable to load onto the wire.The procedure was completed with another of the same rotaburr.No patient complications were reported and the patient's status was fine.

Manufacturer Narrative

Device evaluated by mfr: the device was returned for analysis.Visual inspection revealed that the body of the rotawire was broken at approximately 238.2cm from the proximal end.The other section measures approximately 92.1cm from the distal tip.No foreign matters were found.Dimensional inspection of the overall length could not be performed due to device condition.The outer diameter (od) of distal tip, the middle and of the proximal section of the device were within specification.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.Dfu states: "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 (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.Gently advance or retract the burr while it is in high-speed rotary motion.In instances when long ablation runs are required - particularly in calcified, angulated lesions - reposition the guidewire to expose a previously unused segment or exchange the guidewire to prevent damage." (b)(4).

Event Description

Same case as mdr id: 2134265-2017-13374 and 2134265-2018-00424.It was reported that foreign matter was observed on the rotawire and a rotawire fracture occurred.The target lesion was located in the anterior tibial artery of the right lower leg.A peripheral rotawire¿ and a peripheral rotalink® plus were selected for use.There were two rotawires that were pulled out from its hoop and white debris was observed at the proximal end.Subsequently, the second rotawire was used during platforming.When the physician loaded the rotaburr onto the rotawire, it was noted that the wire snapped in half.The rotawire was exchanged with another of the same device and the rotaburr was loaded onto it.However, the burr was unable to load onto the wire.The procedure was completed with another of the same rotaburr.No patient complications were reported and the patient's status was fine.

• Brand Name: PERIPHERAL ROTAWIRE¿ AND WIRECLIP® TORQUER
• Type of Device: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC - COSTA RICA (HEREDIA); 302 parkway; la aurora; heredia ; CS
• Manufacturer (Section G): BOSTON SCIENTIFIC - COSTA RICA (HEREDIA); 302 parkway; la aurora; heredia ; CS
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 7205504
• MDR Text Key: 97952176
• Report Number: 2134265-2017-13373
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121774
• 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
• Report Date: 12/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/11/2019
• Device Model Number: M0011373321
• Device Lot Number: 21245210
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/31/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/11/2017
• 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
• Patient Age: 60 YR