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

Model Number H802232390012

Device Problems Fracture (1260); Kinked (1339)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/11/2014

Event Type  Injury  

Event Description

Same case as: 2134265-2014-04858.It was reported that the tip of the burr and a rotawire detachment occurred.The 99% stenosed, over 20 mm in length, 3.5mm to 4.0mm vessel diameter target lesion was located in the mildly tortuous and severely calcified proximal right coronary artery.A 2.25mm rotalink¿ plus and a rotawire¿ and wireclip¿ torquer was used to treat the target lesion.During the procedure, plain old balloon angioplasty was performed with a 1.5mm and 2.0mm unspecified balloon catheter to treat an in stent restenosis in the right coronary artery caused by a non bsc stent.However, the lesion could not be dilated.A 1.75mm rotaburr cross the lesion and intravascular ultrasound was performed.A circumferential calcification inside the stent was found.The rota 1.75mm was then changed with a rota 2.25mm.Upon ablation, picking motion was performed for 62 seconds with a rotation speed of 230.000rpm maximum.However, the rotation speed decreased by 4000rpm and noticed that the burr was detached from the shaft which was shown in the cineangiocardiogram.The physician cut off the device at the proximal drive shaft sheath and covered with a non bsc catheter as the burr was stuck and the rotawire remained inside the body.They were able to remove the drive shaft sheath without resistance but the tip of the burr was left inside the patients' body.The physician attempted to pass through an unspecified wire between the burr and the vessel wall, but failed.Thoracatomy was then performed to take out the rotawire and the tip of the burr.They were able to removed all of the detached components and found that the rotawire was kinked.The procedure was not completed due to this event.No further patient complications were reported and the patients' status is good.

Manufacturer Narrative

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

Manufacturer Narrative

Device evaluated by mfr.: the device was returned for analysis.Visual and tactile inspection was performed and noted the device was separated in two sections.The first part is located at the middle section is cut on both ends of the wire, moreover the most proximal section of the wire was not returned.Also, the second part which is located at the distal section and spring tip is kinked at 17.7cm approximately from the distal end.All the outer diameter measurements are within the specifications.External analysis from (b)(4) laboratory was done to determine the fracture failure mode.It was noted that mechanical cut was the mode of wire separation.Also, bending fatigue and tension as a mode of wire failure and complementary fracture surface dimensions and characteristics were observed.The batch number is unknown and the manufacturing records for the complaint device could not be reviewed.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: 2134265-2014-04858.It was reported that the tip of the burr and a rotawire detachment occurred.The 99% stenosed, over 20 mm in length, 3.5mm to 4.0mm vessel diameter target lesion was located in the mildly tortuous and severely calcified proximal right coronary artery.A 2.25mm rotalink¿ plus and a rotawire¿ and wireclip¿ torquer was used to treat the target lesion.During the procedure, plain old balloon angioplasty was performed with a 1.5mm and 2.0mm unspecified balloon catheter to treat an in stent restenosis in the right coronary artery caused by a non bsc stent.However, the lesion could not be dilated.A 1.75mm rotaburr cross the lesion and intravascular ultrasound was performed.A circumferential calcification inside the stent was found.The rota 1.75mm was then changed with a rota 2.25mm.Upon ablation, picking motion was performed for 62 seconds with a rotation speed of 230.000rpm maximum.However, the rotation speed decreased by 4000rpm and noticed that the burr was detached from the shaft which was shown in the cineangiocardiogram.The physician cut off the device at the proximal drive shaft sheath and covered with a non bsc catheter as the burr was stuck and the rotawire remained inside the body.They were able to remove the drive shaft sheath without resistance but the tip of the burr was left inside the patients' body.The physician attempted to pass through an unspecified wire between the burr and the vessel wall, but failed.Thoracotomy was then performed to take out the rotawire and the tip of the burr.They were able to removed all of the detached components and found that the rotawire was kinked.The procedure was not completed due to this event.No further patient complications were reported and the patients' status is good.

• Brand Name: ROTAWIRE? AND WIRECLIP? TORQUER
• 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: 3979357
• MDR Text Key: 16632763
• Report Number: 2134265-2014-04859
• 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: 07/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: H802232390012
• Device Catalogue Number: 23239-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/10/2014
• 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: INTRODUCER SHEATH: 8F; GUIDING CATHETER: 8F
• Patient Outcome(s): Required Intervention