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

Model Number 3241

Device Problems Fracture (1260); Use of Device Problem (1670); Device Damaged by Another Device (2915); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Perforation (2001); Pericardial Effusion (3271)

Event Date 08/08/2018

Event Type  Injury  

Manufacturer Narrative

Initial reporter phone: (b)(6).

Event Description

It was reported that the rotawire broke as well as a perforation and pericardial effusion.A rotational atherectomy treatment procedure was being performed in the marginal branch as well as the circumflex (cx).The cx was reported to be 90% stenosed, tortuous with severe calcification.The marginal branch was treated with a 1.25mm rotablator rotalink plus over a 330cm rotawire.Multiple runs were made for 25 seconds at 180,000 rpm lasting more than five minutes with no effect on the calcification using the pecking method per dfu.The physician advanced a new 330cm rotawire in the cx without any problems and removed the previous rotawire.During removal of the rotawire from the vessel, the spiral of the wire tip became stretched.The wire was removed intact.The same 1.25mm rotablator rotalink plus was then advanced over the new 330cm rotawire in the cx and rotablation was started.It was then noted the new rotawire was broken and the burr had perforated the vessel.The perforation was treated with all interventional techniques, followed by pericardial puncture and monitoring.The fractured portion of the rotawire was unable to be retrieved and remains in the patient's distal cx.No further complications were reported and the patient was reported to be stable post procedure.

Event Description

It was reported that the rotawire broke as well as a perforation and pericardial effusion.A rotational atherectomy treatment procedure was being performed in the marginal branch as well as the circumflex (cx).The cx was reported to be 90% stenosed, tortuous with severe calcification.The marginal branch was treated with a 1.25mm rotablator rotalink plus over a 330cm rotawire.Multiple runs were made for 25 seconds at 180,000rpm lasting more than five minutes with no effect on the calcification using the pecking method per dfu.The physician advanced a new 330cm rotawire in the cx without any problems and removed the previous rotawire.During removal of the rotawire from the vessel, the spiral of the wire tip became stretched.The wire was removed intact.The same 1.25mm rotablator rotalink plus was then advanced over the new 330cm rotawire in the cx and rotablation was started.It was then noted the new rotawire was broken and the burr had perforated the vessel.The perforation was treated with all interventional techniques, followed by pericardial puncture and monitoring.The fractured portion of the rotawire was unable to be retrieved and remains in the patients distal cx.No further complications were reported and the patient was reported to be stable post procedure.Returned product consisted of the rotalink burr device.The advancer unit was not returned.The handshake connection, sheath, coil and burr were microscopically and visually examined.The coil is stretched.Microscopic examination of the device revealed that the annulus was damaged and not rounded which is consistent with damage seen with the use of a rotawire.There are numerous sheath kinks.Functional testing was completed with a.009" rotawire.The rotawire was inserted through the burr and advanced through the entire length of the device with no issue.Functional testing was performed by connecting the burr catheter to a test advancer and the advancer was attached to the rotablator control console system.The rotablator system was able to reach optimum speed with no abnormal noise and the burr rotated with no issues.Inspection of the remainder of the device presented no other damage or irregularities.

Manufacturer Narrative

(b)(6).

Manufacturer Narrative

(b)(6).Correction: conclusion code previously reported as no problem detected 67 has been corrected to adverse event related to procedure 4311.Bsc received anonymized media from the hospital.The media was reviewed by a bsc medical director.The following is a summary of the review: the case begins with diagnostic angiography via the radial approach using an amplatz guiding catheter.Arteriograms demonstrated a tight, but not heavily calcified, stenosis in the mid circumflex (lcx) involving the origin of an obtuse marginal (om) branch.The images demonstrated pci to a bifurcation lesion in the mid circumflex (lcx).After unsuccessful rotational atherectomy (ra) to the obtuse marginal (om) branch, the rotawire was repositioned and an attempt was made to ra to the distal lcx.The rotawire tip separated in the distal lcx.This was also apparently associated with vessel perforation (no evidence of contrast extravasation is seen on the images provided) requiring pericardiocentesis and pericardial drain placement.Bleeding through the perforation was apparently controlled by balloon tamponade.At the end of the procedure diminished flow (timi 2) was seen in the om and no flow (timi 0) was seen in the distal lcx.

Event Description

It was reported that the rotawire broke as well as a perforation and pericardial effusion.A rotational atherectomy treatment procedure was being performed in the marginal branch as well as the circumflex (cx).The cx was reported to be 90% stenosed, tortuous with severe calcification.The marginal branch was treated with a 1.25mm rotablator rotalink plus over a 330cm rotawire.Multiple runs were made for 25 seconds at 180,000rpm lasting more than five minutes with no effect on the calcification using the pecking method per dfu.The physician advanced a new 330cm rotawire in the cx without any problems and removed the previous rotawire.During removal of the rotawire from the vessel, the spiral of the wire tip became stretched.The wire was removed intact.The same 1.25mm rotablator rotalink plus was then advanced over the new 330cm rotawire in the cx and rotablation was started.It was then noted the new rotawire was broken and the burr had perforated the vessel.The perforation was treated with all interventional techniques, followed by pericardial puncture and monitoring.The fractured portion of the rotawire was unable to be retrieved and remains in the patients distal cx.No further complications were reported and the patient was reported to be stable post procedure.Returned product consisted of the rotalink burr device.The advancer unit was not returned.The handshake connection, sheath, coil and burr were microscopically and visually examined.The coil is stretched.Microscopic examination of the device revealed that the annulus was damaged and not rounded which is consistent with damage seen with the use of a rotawire.There are numerous sheath kinks.Functional testing was completed with a.009" rotawire.The rotawire was inserted through the burr and advanced through the entire length of the device with no issue.Functional testing was performed by connecting the burr catheter to a test advancer and the advancer was attached to the rotablator control console system.The rotablator system was able to reach optimum speed with no abnormal noise and the burr rotated with no issues.Inspection of the remainder of the device presented no other damage or irregularities.

• Brand Name: ROTALINK PLUS
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 7844316
• MDR Text Key: 119151102
• Report Number: 2134265-2018-60562
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729316411
• UDI-Public: 08714729316411
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 02/25/2019

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 Expiration Date: 04/14/2020
• Device Model Number: 3241
• Device Catalogue Number: 3241
• Device Lot Number: 0022119880
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2018
• Initial Date Manufacturer Received: 08/09/2018
• Initial Date FDA Received: 09/04/2018
• Supplement Dates Manufacturer Received: 09/14/2018; 01/31/2019
• Supplement Dates FDA Received: 10/03/2018; 02/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR