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

Model Number H749236310150

Device Problem Device Packaging Compromised (2916)

Patient Problem No Patient Involvement (2645)

Event Date 10/19/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event 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.

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 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
• 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: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 7007888
• MDR Text Key: 92059472
• Report Number: 2134265-2017-10941
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729316473
• UDI-Public: 08714729316473
• Combination Product (y/n): N
• PMA/PMN Number: P900056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/19/2017
• Initial Date FDA Received: 11/07/2017
• Supplement Dates Manufacturer Received: 11/16/2017
• Supplement Dates FDA Received: 12/05/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/09/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1