MAUDE Adverse Event Report: BOSTON SCIENTIFIC - SAN JOSE ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM; CATHETER, CORONARY, ATHERECTOMY

Model Number UNK605

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 06/13/2018

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr: the device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).

Event Description

Same case as mdr id: 2134265-2018-06499.It was reported that the speed was unstable.A rotalink¿ advancer and a rotablator console were selected for use.During preparation, the cables were connected respectively to the console and the compressed air pressure is evaluated at 100 psi.Then, the physician introduced the rotawire to the proximal end of the 1.50mm rotalink¿ burr and advancer already mounted obtaining it in its back.The draw test then was realized; however, it was noted that the burr rotates in fluctuating revolutions.The set operational speed was at 150,000 rpms but it went from 220,000 to 120,000 in less than 3 seconds with the pedal fully depressed.Also, the sound of revolutions was unusual from the advancer.It was assessed that everything was well connected with the required pressure so the physician tried again obtaining the same results.Physician decided to remove the rotaburr and disconnected the advancer from the rotalink burr.It was then noted that the rotalink burr was slightly bent in a segment proximal the handshake connection.The procedure was completed with a 1.75mm rotalink¿ plus.No patient complications were reported and patient's status was stable.

• Brand Name: ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC - SAN JOSE; 150 baytech drive; san jose CA 95134
• Manufacturer (Section G): BOSTON SCIENTIFIC - SAN JOSE; 150 baytech drive; san jose CA 95134
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 7664145
• MDR Text Key: 113340669
• Report Number: 2134265-2018-06260
• 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: 06/14/2018

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 Model Number: UNK605
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/14/2018
• Initial Date FDA Received: 07/05/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 71 YR