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

Model Number H749236310040

Device Problem Obstruction of Flow (2423)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

Same case as: 2134265-2014-07058.Reportable based on device analysis completed on 28oct2014.It was reported that the catheter could not be loaded on the wire.A 1.75mm rotalink¿ plus and a 330cm rotawire¿ and wireclip¿ torquer were selected to treat the target lesion.However, it was not possible to load the rotalink onto the rotawire; it seemed the the burr did not have an end hole.The device did not go inside the patient.No patient complications were reported.However, device analysis revealed a piece of guidewire inside the annulus of the burr.

Manufacturer Narrative

(b)(4).Only the catheter portion of the device was returned for analysis.A visual examination of the complaint unit was carried out.The handshake connection was inspected and no damage was noted.The annulus of the burr was inspected and found to be damaged and the annulus was found to be blocked by a piece of the guidewire.A test guidewire was attempted to be loaded through the handshake connector of the catheter.The wire was able to track down through the coil however a resistance was met and the wire could not push out the broken wire from the annulus.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).

• 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: 4277175
• MDR Text Key: 17291699
• Report Number: 2134265-2014-07057
• Device Sequence Number: 1
• Product Code: MCX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P900056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 10/28/2014

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: 06/30/2015
• Device Model Number: H749236310040
• Device Catalogue Number: 23631-004
• Device Lot Number: 16218914
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/28/2014
• Initial Date FDA Received: 11/25/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/09/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1