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

Model Number H802228240022

Device Problems Fracture (1260); Migration or Expulsion of Device (1395)

Patient Problem Perforation of Vessels (2135)

Event Date 02/23/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Same case as mdr ids: 2134265-2017-02255 and 2134265-2017-02256.It was reported that a wire tip was detached and vessel perforation occurred.The target lesion was located in the severely tortuous and severely calcified mid to proximal right coronary artery (rca).A 330cm rotawire¿ , 1.75mm and 1.25mm rotalink¿ plus were selected for use.During the procedure, the physician used the 1.75mm rotaburr first.After that, a smaller size of 1.25mm burr was used.Ablation was performed 4 times at 200,000rpm with a duration of 20 seconds.During removal of the device, it was noted that the wire became detached, migrated to the patient's blood vessel and could not be retrieved.It was alleged that although there was wire separation when removing the 1.25mm burr, there is a possibility that wire separation occurred when using the 1.75mm burr.Furthermore, it was noted that with the two points where the wire became detached, no wire perforation occurred at the distal side.However, perforation occurred in the wire tip proximal side.Eventually, the procedure was shifted to surgery.The detached wire tip was retrieved which was longer than the usual and the devices were removed out from the patient¿s body.No further patient complications were reported.

Manufacturer Narrative

Device evaluated by manufacturer: the device was returned for analysis.A visual examination of the returned device confirmed broken at 314cm from proximal section and it is kinked in several sections.The sections broken returned include the distal section kinked with the spring tip attached and, one piece of wire.Dimensional inspection was done and the overall length could not be measured due to device condition.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is operational context as device performance was limited due to anatomical procedural factors.(b)(4).

Event Description

Same case as mdr ids: 2134265-2017-02255 and 2134265-2017-02256.It was reported that a wire tip was detached and vessel perforation occurred.The target lesion was located in the severely tortuous and severely calcified mid to proximal right coronary artery (rca).A 330cm rotawire¿, 1.75mm and 1.25mm rotalink¿ plus were selected for use.During the procedure, the physician used the 1.75mm rotaburr first.After that, a smaller size of 1.25mm burr was used.Ablation was performed 4 times at 200,000rpm with a duration of 20 seconds.During removal of the device, it was noted that the wire became detached, migrated to the patient's blood vessel and could not be retrieved.It was alleged that although there was wire separation when removing the 1.25mm burr, there is a possibility that wire separation occurred when using the 1.75mm burr.Furthermore, it was noted that with the two points where the wire became detached, no wire perforation occurred at the distal side.However, perforation occurred in the wire tip proximal side.Eventually, the procedure was shifted to surgery.The detached wire tip was retrieved which was longer than the usual and the devices were removed out from the patient¿s body.No further 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: 6415458
• MDR Text Key: 70298725
• Report Number: 2134265-2017-02254
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729195566
• UDI-Public: (01)08714729195566(17)20181122(10)0019991057.
• 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: 02/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/22/2018
• Device Model Number: H802228240022
• Device Catalogue Number: 22824-002
• Device Lot Number: 0019991057
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/27/2017
• Initial Date FDA Received: 03/17/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/23/2016
• 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 Outcome(s): Required Intervention