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

Model Number 3243

Device Problems Malposition of Device (2616); Output Problem (3005)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/11/2019

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr: the returned complaint device consisted of a rotapro device.The burr catheter was received attached to the advancer.The advancer, handshake connections, sheath, coil, burr and annulus were microscopically and visually examined.There are numerous sheath kinks.The sheath is completely torn at the strain relief.Microscopic examination of the device revealed that the annulus was damaged and not rounded.The coil is stretched.Functional testing was performed using a test.009 rotawire.A test.009 rotawire was inserted through the burr and advanced through the entire length of the device with no resistance.Functional testing was performed by connecting the advancer to the rotablator control console system.The rotablator system was able to reach optimum speed with no issues.Inspection of the remainder of the device presented no other damage or irregularities.

Event Description

It was reported that the device jumped forward during the procedure.The mildly tortuous target lesion was located in the obtuse marginal circumflex artery.A couple of successful passes were made with the 1.25mm rotapro device.While attempting the third pass, the device speed slowed down drastically and then the burr jumped forward about 3 cm on its own into a non-diseased area.The burr was not repositioned.The device was pulled out and the case was completed successfully.An unspecified stent was placed in the non-diseased area as a precautionary measure.There were no patient complications and the patient's status is fine.

• Brand Name: ROTAPRO
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC SCIMED, INC; two scimed place; maple grove MN 55311
• Manufacturer Contact: sonali arangil ; two scimed place; maple grove, MN 55311 ; 6515827403
• MDR Report Key: 8404088
• MDR Text Key: 138251516
• Report Number: 2134265-2019-02231
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729893356
• UDI-Public: 08714729893356
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P900056/S166
• 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: 03/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/27/2020
• Device Model Number: 3243
• Device Catalogue Number: 3243
• Device Lot Number: 21798279
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/13/2019
• Initial Date FDA Received: 03/08/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1