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

Model Number H749236310040

Device Problem Packaging Problem (3007)

Patient Problem No Patient Involvement (2645)

Event Date 01/15/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).

Event Description

It was reported that the device had a labeling issue.A 1.75mm rotalink¿ plus was selected for use.During preparation, the packaging and delivery note on product shows the size for the rotalink as 1.75mm.However, it was noticed that sterile packaging as well the rotalink itself was showed as 1.50mm rotalink.Procedure was completed using a different device.No patient complications were reported and patient's status was stable.

Manufacturer Narrative

Device avail.For eval, returned to mfr.On, device returned to mfr, device evaluated by mfr, eval summary attached, method codes, result codes, conclusion codes updated.Device evaluated by mfr: device returned for analysis.Returned product consisted of the rotablator rotalink plus device.The packaging, labels and advancer were visually examined.The rotablator rotalink plus device was received in an opened shelf box and product pouch.Inside the opened product pouch was a packing list and a label that was cut-off of a package.The batch number on the shelf box and packing list was 20960240, which is for a 1.75mm rotablator rotalink plus device.The batch number on the cut-off label and rotablator rotalink plus device was 20922646, which is for a 1.5mm rotablator rotalink plus device.Photos and analysis details of the returned device were sent to engineering in cork for further inspection.Their investigation concluded that the lot history records indicate that the 1.50mm lot was processed and shipped from bsc cork prior to commencement of the 1.75mm lot at the inside packaging station within the cleanroom environment.Inspection of device presented no damage.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The investigation conclusion was unable to be determined.(b)(4).

Event Description

It was reported that the device had a labeling issue.A 1.75mm rotalink¿ plus was selected for use.During preparation, the packaging and delivery note on product shows the size for the rotalink as 1.75mm.However, it was noticed that sterile packaging as well the rotalink itself was showed as 1.50mm rotalink.Procedure was completed using a different device.No patient complications were reported and patient's status was stable.

• 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: 7244998
• MDR Text Key: 99325792
• Report Number: 2134265-2018-01104
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729228370
• UDI-Public: 08714729228370
• Combination Product (y/n): N
• Reporter Country Code: ZA
• PMA/PMN Number: P900056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/15/2018

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: 07/03/2019
• Device Model Number: H749236310040
• Device Catalogue Number: 23631-004
• Device Lot Number: 20960240
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/15/2018
• Initial Date FDA Received: 02/06/2018
• Supplement Dates Manufacturer Received: 03/08/2018
• Supplement Dates FDA Received: 03/29/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/11/2017
• 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
• Patient Age: 82 YR