MAUDE Adverse Event Report: BOSTON SCIENTIFIC PERIPHERAL ROTALINK PLUS BURR CATHETER; CATHETER CORONARY, ATHERECTOMY

Catalog Number M0011401500

Device Problems Entrapment of Device (1212); Difficult to Remove (1528); Sticking (1597)

Patient Problems Death (1802); Sudden Cardiac Death (2510)

Event Date 03/07/2018

Event Type  Death  

Event Description

While attempting to rotablator (boston scientific 1.50mm peripheral rotalink plus) the circumflex coronary artery, the burr got stuck in calcium.Multiple and different ways of dislodging device were attempted with no success.Pt went to surgery to remove.Pt went to surgery for redo sternotomy with cabg x3 vessels and extraction of the retained intracardiac rotablator wire.Pt to icu after surgery, code blue called (cardiac arrest), resuscitative efforts without return of pulse and circulation.The code was called and time of death was at 1856.On (b)(6) 2018 left heart catheterization, left ventriculogram, coronary angiography, rotational atherectomy of the left main and circumflex coronary artery, balloon angioplasty of the proximal circumflex, insertion impella lv assist device (b)(6) 2018 surgery performed: redo sternotomy with cabg x 3 vessels and reharvesting of old lima graft, extraction of retained intracardiac rotablator wire, endoscopic harvest of left greater saphenous vein.Dates of use: (b)(6) 2018.Diagnosis or reason for use: rotational atherectomy of coronary artery."is the product compounded: no, is the product over-the-counter: no.".

• Brand Name: PERIPHERAL ROTALINK PLUS BURR CATHETER
• Type of Device: CATHETER CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC; EI
• MDR Report Key: 7337360
• MDR Text Key: 102467577
• Report Number: MW5075839
• Device Sequence Number: 1
• Product Code: MCX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/12/2018

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/26/2019
• Device Catalogue Number: M0011401500
• Device Lot Number: 20813815
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/13/2018
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 80 YR
• Patient Weight: 113