MAUDE Adverse Event Report: BOSTON SCIENTIFIC - CORK PERIPHERAL ROTALINK® PLUS; CATHETER, PERIPHERAL, ATHERECTOMY

Model Number M0011401500

Device Problem Contamination (1120)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by manufacturer: the device was not returned for analysis.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

It was reported that the burr caught the drape.A peripheral rotalink® plus was selected for use.During preparation outside patient's body, the rotation of the device was tested.The device moved as the physician tested the rpms.Consequently, it was noticed that the burr became caught on the blue table drape and the foreign material wrapped around the burr.The device did not enter the patient's body.No patient complications were reported.

• Brand Name: PERIPHERAL ROTALINK® PLUS
• Type of Device: CATHETER, PERIPHERAL, 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: 6602301
• MDR Text Key: 76408388
• Report Number: 2134265-2017-05266
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 08714729838906
• UDI-Public: (01)08714729838906(17)20181130(10)20003891
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121774
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2018
• Device Model Number: M0011401500
• Device Lot Number: 20003891
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/11/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2016
• 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