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

Model Number M0011401250

Device Problem Device Packaging Compromised (2916)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the device sterility was compromised.A 1.25mm peripheral rotalink® plus was selected for use.During unpacking, it was noted that the inner package of the device was opened.The procedure was completed with another device.No patient complications were reported.

Manufacturer Narrative

Device evaluated by manufacturer: the device was returned for analysis.Returned product consisted of the rotablator rotalink plus device for this complaint; however the packaging was not returned for analysis.It was reported that the box and pouch would not fit into return kit, so the customer just made sure the device was returned.The packaging should have been visually examined/inspected; however it was not returned for analysis.The device was visually inspected and there was no damage or irregularities to the device.Inspection of the device presented no damage or irregularities.The investigation conclusion was unable to be determined.(b)(4).

Event Description

It was reported that the device sterility was compromised.A 1.25mm peripheral rotalink® plus was selected for use.During unpacking, it was noted that the inner package of the device was opened.The procedure was completed with another device.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: 7100538
• MDR Text Key: 94975984
• Report Number: 2134265-2017-12072
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133566
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/20/2017

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: 01/31/2019
• Device Model Number: M0011401250
• Device Lot Number: 20116585
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/20/2017
• Initial Date FDA Received: 12/08/2017
• Supplement Dates Manufacturer Received: 01/09/2018
• Supplement Dates FDA Received: 01/30/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/09/2017
• 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