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

Model Number H802228240022

Device Problem Unintended Movement (3026)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/08/2017

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: 18 years or older.(b)(4).

Event Description

Same case as mdr id: 2134265-2017-13099.It was reported that the tip of the rotawire was rotating inside the blood vessel.The target lesion was located in the severely calcified left main trunk.A 1.75mm rotalink¿ plus and a 330cm rotawire¿ were selected for use.During the procedure, a 0.014" non bsc guidewire was advanced to the target lesion and then a non bsc microcatheter was inserted and replaced with the rotawire.When the rotawire was advanced inside the guiding catheter in order to reach the 1.75mm rotaburr up to lesion by dynaglide, it was noted under fluoroscopy that the tip of the rotawire was found rotating in the blood vessel.Afterwards, the rotawire was slightly withdrawn and was advanced again through dynaglide mode.Ablation was then performed and was completed with the same rotalink and the same rotawire.No patient complications were reported.

Manufacturer Narrative

Device evaluated by manufacturer: the device was returned for analysis inside a hoop.The device distal tip was kinked and the body kinked located approximately at 140cm from the proximal end.The solder fillet of the spring tip was missing.The surface of the guidewire was thoroughly inspected and no abnormalities were found, it looks smooth and clean.Overall length, outer diameters of the distal tip, middle, and the proximal section of the device were within specification.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.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: "never advance the rotating burr to the point of contact with the guidewire spring tip, as this may result in distal detachment and embolization of the tip." (b)(4).

Event Description

Same case as mdr id: 2134265-2017-13099.It was reported that the tip of the rotawire was rotating inside the blood vessel.The target lesion was located in the severely calcified left main trunk.A 1.75mm rotalink¿ plus and a 330cm rotawire¿ were selected for use.During the procedure, a 0.014" non bsc guidewire was advanced to the target lesion and then a non bsc microcatheter was inserted and replaced with the rotawire.When the rotawire was advanced inside the guiding catheter in order to reach the 1.75mm rotaburr up to lesion by dynaglide, it was noted under fluoroscopy that the tip of the rotawire was found rotating in the blood vessel.Afterwards, the rotawire was slightly withdrawn and was advanced again through dynaglide mode.Ablation was then performed and was completed with the same rotalink and the same rotawire.No patient complications were reported.

• Brand Name: ROTAWIRE¿ AND WIRECLIP¿ TORQUER
• Type of Device: CATHETER, CORONARY, 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: 7141701
• MDR Text Key: 95644167
• Report Number: 2134265-2017-13098
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729195566
• UDI-Public: 08714729195566
• 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,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/08/2017

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 Expiration Date: 09/04/2019
• Device Model Number: H802228240022
• Device Catalogue Number: 22824-002
• Device Lot Number: 0021091852
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/08/2017
• Initial Date FDA Received: 12/22/2017
• Supplement Dates Manufacturer Received: 01/19/2018
• Supplement Dates FDA Received: 02/09/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/04/2017
• 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