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

Model Number H802228240022

Device Problem Detachment Of Device Component (1104)

Patient Problems Perforation of Vessels (2135); Device Embedded In Tissue or Plaque (3165)

Event Date 05/11/2018

Event Type  Injury  

Manufacturer Narrative

Age at time of event: 18 years or older.(b)(4).Device evaluated by mfr: it is indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.(b)(4).

Event Description

Same case as mdr id: 2134265-2018-04960.It was reported that the rotawire became detached and remained inside patient's body and patient experienced vessel perforation.The 99% stenosed target lesion was located in the mildly tortuous and severely calcified circumflex (cx) artery.A 1.25 mm rotalink¿ plus and a 330 cm rotawire¿ were selected for use.During the procedure, rotawire was advanced to the lesion followed by the 1.25 mm burr.Ablation was then performed five times with an average of 150,000 rpm at 22 seconds each.During the sixth ablation, it was noted that the burr cut through the rotawire and the detached portion exited the cx into the free space of the heart.The burr was quickly removed from the patient's body by pulling the rotawire and an injection with contrast dye was performed on the vessel where it was noticed that perforation occurred at the ostial portion of the cx.The tip of the rotawire was also seen in the distal cx.A 2.5 x 20 emerge balloon was inserted to the ostial cx and was then inflated to 12 atm for 10 mins.For 3 separate times.At the conclusion of the 3rd inflation, the perforation appeared to be sealed.An echo was performed during inflations with no noticeable pericardial effusion.Patient was then observed for 30 mins., followed by another injection of contrast dye and confirmed that perforation was contained.The physician attempted to remove the rotawire tip with a snare without success.The rotawire tip remained in the distal cx.The physician advised that the patient may be brought back once the vessel has healed to snare the detached wire from the cx.The procedure was completed with a different device.No further patient complications were reported and the patient's status was stable.

• 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: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 7566857
• MDR Text Key: 109998957
• Report Number: 2134265-2018-04968
• Device Sequence Number: 1
• Product Code: MCX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P900056
• 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
• Report Date: 05/14/2018

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 Model Number: H802228240022
• Device Catalogue Number: 22824-002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/14/2018
• Initial Date FDA Received: 06/04/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other; Required Intervention