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

Model Number H749236310030

Device Problem Thermal Decomposition of Device (1071)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/22/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Age at time of event: 18 years or older.(b)(4).

Event Description

It was reported that the burr got burnt over rota wire.The 90% stenosed target lesion was located in the mildly tortuous and severely calcified left anterior descending artery.A 1.50mm rotalink plus was selected to be used.During the procedure, fast rotation was performed when setting up the device.Then, it was noted that burr got burnt over the rotawire although the cocktail water was filled.The procedure was completed with another of the same device.No patient complications were reported and patient's condition was good.

Manufacturer Narrative

Device evaluated by manufacturer: the device was returned for analysis.A visual examination of the complaint unit was carried out and no issues were noted.The advancer knob was locked upon return in a backward position; it was loosened and advanced in order to inspect the handshake connection.The handshake connection was inspected and no damage was noted.A handshake connection test was attempted to examine the integrity of the connection and no issues were noted.The drive shaft, coil and sheath were inspected and there was no damage noted.The burr was microscopically examined.The annulus was noted to be blocked/ damaged.A scratch test was performed to confirm if the returned burrs cutting action was acceptable.The diamond plated area of the burr was scratched along the side of a single edge blade.When the side of the blade was visually examined, a scratch mark from where the burr came into contact with the side of the blade was noted.This confirmed that the burrs cutting action was acceptable.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is operational context as device performance was limited due to anatomical procedural factors.(b)(4).

Event Description

It was reported that the burr got burnt over rota wire.The 90% stenosed target lesion was located in the mildly tortuous and severely calcified left anterior descending artery.A 1.50mm rotalink¿ plus was selected to be used.During the procedure, fast rotation was performed when setting up the device.Then, it was noted that burr got burnt over the rotawire although the cocktail water was filled.The procedure was completed with another of the same device.No patient complications were reported and patient's condition was good.

• 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: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 5523170
• MDR Text Key: 41067420
• Report Number: 2134265-2016-02328
• 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,distri
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/25/2016

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: 10/31/2017
• Device Model Number: H749236310030
• Device Catalogue Number: 23631-003
• Device Lot Number: 0018637429
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/25/2016
• Initial Date FDA Received: 03/24/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/17/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/18/2015
• 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