MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM; CATHETER, CORONARY, ATHERECTOMY

Device Problem Break (1069)

Patient Problem Perforation of Vessels (2135)

Event Date 04/02/2020

Event Type  Injury  

Manufacturer Narrative

Initial reporter facility name: (b)(6).Umihiko kaneko, md, yoshifumi kashima, md, takuro sugie, md, daitaro kanno, md, and tsutomu fujita, md, rotablator driveshaft fracture due to significant proximal tortuosity and enlargement causing massive coronary perforation, korean circulation journal, volume 50, issue 11, nov 2020, pages 1048-1050, pissn 1738-5520 eissn 1738-5555, https://doi.Org/10.4070/kcj.2020.0136.

Event Description

It was reported via journal article that the driveshaft fractured and a perforation occurred.The target lesion was located in the calcified left circumflex artery (lcx) lesion with severe proximal tortuosity and enlargement.A 1.5mm rotablator rotational atherectomy system and a rotawire crossed the lesion with a rotational speed of 220,000 rpm.During a final polishing run, the burr collided with the lesion, and the driveshaft prolapsed into the distal left main coronary artery (lm).The driveshaft was suddenly fractured, resulting in ellis type iii perforation of the distal left main with vascular ectasia and left circumflex artery.After the implantation of two polytetrafluoroethylene covered stents, the left coronary angiography revealed no contrast extravasation.Angiography of the bypass graft revealed persistent contrast extravasation of the left internal mammary artery to the left anterior descending artery graft, requiring surgical repair by filling and sealing the perforation site with surgical cotton.

• Brand Name: ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC LIMITED; business & technology park; model farm road; cork ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12392769
• MDR Text Key: 268965256
• Report Number: 2134265-2021-11016
• Device Sequence Number: 1
• Product Code: MCX
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 08/31/2021

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/10/2021
• Initial Date FDA Received: 08/31/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR