MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (COYOL) ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM; CATHETER, CORONARY, ATHERECTOMY

Model Number UNK509

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Intimal Dissection (1333); Aneurysm (1708); Hematoma (1884)

Event Type  Injury  

Manufacturer Narrative

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: 2134265-2017-11341 and 2134265-2017-11342.It was reported a vascular dissection, hematoma and an aneurysm were observed.The severely stenosed target lesion was located in the severely calcified mid left anterior descending artery (lad).During a rotational atherectomy treatment procedure, ablation was performed at 180,000 rpm using a 1.50mm rotalink plus and a floppy rotawire.The 1.50 rota burr was replaced with a 1.75mm rotalink plus and ablation was again performed at 180,000rpm.A vascular dissection and hematoma were then observed at the tortuous area of the proximal part of the lesion.An unspecified stent was placed as treatment and the procedure was completed.During follow-up, two weeks after the procedure, an aneurysm was observed in the proximal part of the lesion, however treatment was not performed because worsening of hemodynamics was not observed.Enlargement of the aneurysm was not observed, and there were no problem with the patient's condition.

• Brand Name: ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM
• 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: 7038605
• MDR Text Key: 92287142
• Report Number: 2134265-2017-11343
• 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: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/26/2017

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?: No
• Device Operator: Health Professional
• Device Model Number: UNK509
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/26/2017
• Initial Date FDA Received: 11/16/2017
• 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): Required Intervention
• Patient Age: 75 YR