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

Model Number H802227680020

Device Problem Connection Problem (2900)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/08/2014

Event Type  malfunction  

Event Description

Same case as: 2134265-2015-00848.Reportable based on device analysis completed on 29jan2015.It was reported that a burr catheter connection was kinked.A 1.25mm rotalink¿ burr and a rotawire were selected to treat the target lesion.During the procedure, outside the patient, it was noted that the burr catheter connection was kinked which was connected to the advancer.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.However, device analysis revealed that a guide wire could not be removed from the burr.

Manufacturer Narrative

Age at time of event: 18 years or older.Device evaluated by mfr.: the device was returned for analysis.A visual examination of the complaint unit was carried out and no issues were noted.The handshake connection was inspected and no damage was noted.The coil proximal to the handshake connection was observed to be kinked.A guide wire was returned running through the device.An attempt was made to remove the guide wire but a resistance was felt, possibly due to the kink in the coil and the guide wire could not be removed.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).

• Brand Name: ROTALINK? BURR
• 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: 4545739
• MDR Text Key: 5518472
• Report Number: 2134265-2015-00718
• Device Sequence Number: 1
• Product Code: MCX
• 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: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/29/2015

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: 02/29/2016
• Device Model Number: H802227680020
• Device Catalogue Number: 22768-002
• Device Lot Number: 0016839038
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/29/2015
• Initial Date FDA Received: 02/25/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/26/2014
• 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