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

Model Number	H749236310150
Medical Device Problem Code	Device Packaging Compromised (2916)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/19/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that the seal was opened.A 2.15mm rotalink plus was selected to be used; however, the seal of the device was found to be opened.No patient involvement was reported.
Additional Manufacturer Narrative
Device evaluated by mfr., eval summary attached, method codes, result codes, and conclusion codes updated device evaluated by mfr: the device was returned for analysis.Returned product consisted of shelf box containing an unopened rotablator rotalink plus device.One of the closure strips on the shelf box was pulled/peeled back and the other one had evidence that it was peeled back and placed back done in a different location on the box.There was adhesive adhered to the box around the closure strips, indicating the closure strips were applied and the seal was not compromised when the device left manufacturing.The rotablator plus device product pouch/tray was returned inside the shelf box unopened with no damage or compromised seal.Inspection of the remainder of the packaging/device, apart from the observed damage, revealed no other damage or irregularities.No other issues were identified during the product analysis.The investigation conclusion is handling damage as the complaint was caused by handling of the device or portion of the device without direct patient contact.(b)(4).
Event or Problem Description
It was reported that the seal was opened.A 2.15mm rotalink¿ plus was selected to be used; however, the seal of the device was found to be opened.No patient involvement was reported.

• Brand Name: ROTALINK¿ PLUS
• Common Device Name: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC - CORK; business and technology park; model farm road; cork ; EI
• MDR Report Key: 7007888
• Report Number: 2134265-2017-10941
• Device Sequence Number: 1352380
• Product Code: MCX
• UDI-Device Identifier: 08714729316473
• UDI-Public: 08714729316473
• Combination Product (Y/N): N
• PMA/510(K) Number: P900056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/19/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/09/2019
• Device Model Number: H749236310150
• Device Catalogue Number: 23631-015
• Device Lot Number: 0020619742
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2017
• Initial Date Received by Manufacturer: 10/19/2017
• Supplement Date Received by Manufacturer: 11/16/2017
• Initial Report FDA Received Date: 11/07/2017
• Supplement Report FDA Received Date: 12/05/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1