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

Model Number H749236310030

Device Problems Kinked (1339); Device Damaged Prior to Use (2284); Torn Material (3024); Noise, Audible (3273)

Patient Problem No Patient Involvement (2645)

Event Date 03/11/2014

Event Type  malfunction  

Event Description

Same case as mdr id: 2134265-2014-02100.It was reported that a sheath became torn.A 90% stenosed target lesion was located in a severely calcified and moderately tortuous middle section of the left anterior descending artery.A 1.50mm rotalink plus was used for a percutaneous coronary intervention.During preparation, it was observed that the device was not able to increase the rotational speed up to 200000.A high pitched sound was noted 5 seconds after the pedal was stepped which was further described as a stall sound.It was also noted that the rota burr was kinked.Furthermore, two parts of the resin cover noted in the kinked portion was twisted and torn and the rotational speed was at about 170000.The physician or the staff further noticed that when the speed was set, the rotawire was not straight but slightly meandering which was further described as curved.It was possible that the status of the wire contribute to the event.The procedure was complete with another of the same device.No patient complications were reported and the patient's status was good.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Device evaluated by mfr.: the device was returned for analysis.Device evaluation noted that the handshake coil could not be visualized as the distal coil could not be pushed back into the sheath due to the presence of dried saline and two tears in the sheath.The rotablator system was unable to reach optimum speed and the device stalled.Upon inspection it was noted that saline was not reaching the end of the sheath but was being expelled through the sheath due to the tears.The complaint unit was dismantled and the ultem was found to be melted.This confirms that the tear in the sheath lead to an insufficient supply of saline during the procedure, resulting in a melted ultem, the device stalling and the device unable to reach the optimum speed.The handshake connector of the advancer was free from damage.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

Same case as mdr id: 2134265-2014-02100.It was reported that a sheath became torn.A 90% stenosed target lesion was located in a severely calcified and moderately tortuous middle section of the left anterior descending artery.A 1.50mm rotalink¿ plus was used for a percutaneous coronary intervention.During preparation, it was observed that the device was not able to increase the rotational speed up to 200000.A high pitched sound was noted 5 seconds after the pedal was stepped which was further described as a stall sound.It was also noted that the rota burr was kinked.Furthermore, two parts of the resin cover noted in the kinked portion was twisted and torn and the rotational speed was at about 170000.The physician or the staff further noticed that when the speed was set, the rotawire was not straight but slightly meandering which was further described as curved.It was possible that the status of the wire contribute to the event.The procedure was complete with another of the same device.No patient complications were reported and the patient's status 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: ingrid matte ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 3736326
• MDR Text Key: 4221564
• Report Number: 2134265-2014-01868
• 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: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2014
• Device Model Number: H749236310030
• Device Catalogue Number: 23631-003
• Device Lot Number: 0016401813
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/30/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2013
• 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
• Treatment: ROTA WIRE: GUIDE WIRE