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

Model Number H749236310030

Device Problem Defective Component (2292)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/22/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the brake defeat did not function.During use of a 1.50mm rotalink¿ plus, the brake was not holding the rotawire completely in place.The wire was held in place manually to complete the procedure.The patient was not affected.There were no patient complications and the patient is in stable condition.

Manufacturer Narrative

Device evaluated by mfr.: returned product consisted of the rotablator rotalink plus device.The advancer unit and burr units were received attached together in a single unit.The advancer knob was received loosened in a backward position.There was blood on and in the advancer unit.The brake button and advancer were microscopically and visually inspected and no damage or irregularities were identified.The brake button was received in the as-manufactured position.The brake button was tested and it was able to be pressed and released with no issues.The guidewire used in the procedure was not returned for product analysis, so functional testing was completed with.009¿ rotawire.The rotawire was able to be inserted in the rotablator plus device and the brake worked properly with no issues.The advancer was opened and the brake was examined.There was no damage or irregularities to the brake or the inside the advancer at the brake location.Inspection of the device presented no damage or irregularities.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The root cause is not confirmed as there was no evidence of the alleged issue or any anomalies which could have contributed to the reported difficulty.(b)(4).

Event Description

It was reported that the brake defeat did not function.During use of a 1.50mm rotalink¿ plus, the brake was not holding the rotawire completely in place.The wire was held in place manually to complete the procedure.The patient was not affected.There were no patient complications and the patient is in stable condition.

• Brand Name: ROTALINK¿ PLUS
• 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: 6043542
• MDR Text Key: 57990300
• Report Number: 2134265-2016-09419
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 09/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2017
• Device Model Number: H749236310030
• Device Catalogue Number: 23631-003
• Device Lot Number: 18201699
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/28/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/27/2015
• 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