MAUDE Adverse Event Report: BOSTON SCIENTIFIC - CORK ROTALINK¿ ADVANCER; CATHETER, CORONARY, ATHERECTOMY

Model Number H80222782001A0

Device Problem Defective Component (2292)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/12/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluated by mfr: the advancer was returned for analysis; however, the brake button was not returned.A microscopic and visual inspection of the brake button and advancer were performed.The advancer knob was received tightened in a backward position.The housing was opened to see if the brake was inside, but no brake was found.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is considered handling damage as the event occurred without direct patient contact.(b)(4).

Event Description

It was reported that the brake defeat malfunctioned.A rotalink¿ advancer was selected for use.During the procedure, it was noted that the brake defeat button was damaged.After connecting the device with the gas, the brake defeat burst.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.

• Brand Name: ROTALINK¿ ADVANCER
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC - CORK; business and technology park; model farm road; cork ; EI
• Manufacturer (Section G): BOSTON SCIENTIFIC - CORK; business and technology park; model farm road; cork ; EI
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 6554728
• MDR Text Key: 74749665
• Report Number: 2134265-2017-04392
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729317739
• UDI-Public: (01)08714729317739(17)20181130(10)0020088120.
• Combination Product (y/n): N
• Reporter Country Code: CN
• PMA/PMN Number: P900056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2018
• Device Model Number: H80222782001A0
• Device Catalogue Number: 22782-001A
• Device Lot Number: 0020160518
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/17/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/16/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1