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

Model Number H802227680030

Device Problem Entrapment of Device (1212)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/07/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Same case as mdr id: 2134265-2017-12825.It was reported that the burr became stuck on the rotawire.The target lesion was located in the coronary artery.A 1.50mm rotalink¿ burr and a 330cm rotawire¿ were selected for percutaneous coronary intervention.During procedure, inside patient's body, while advancing the burr, it was noted that the burr became stuck on the rotawire.The procedure was completed with another of the same burr and rotawire.There were no patient complications reported and the patient's condition was stable.

Manufacturer Narrative

Device evaluated by mfr: device was returned for analysis.The coil was kinked at the end of the handshake connection.Inspection of the remainder of the device presented no other damage or irregularities.The guidewire used in the procedure was not returned for product analysis or stuck in the device, so functional testing was completed with a test rotawire.The rotawire was inserted through the burr and advanced up to the handshake connection; however, the rotawire was unable to pass the kink.Product analysis confirmed the reported event due to the kinked coil.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

Same case as mdr id: 2134265-2017-12825.It was reported that the burr became stuck on the rotawire.The target lesion was located in the coronary artery.A 1.50mm rotalink¿ burr and a 330cm rotawire¿ were selected for percutaneous coronary intervention.During procedure, inside patient's body, while advancing the burr, it was noted that the burr became stuck on the rotawire.The procedure was completed with another of the same burr and rotawire.There were no patient complications reported and the patient's condition was stable.

• Brand Name: ROTALINK¿ BURR
• 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: 7137672
• MDR Text Key: 95664601
• Report Number: 2134265-2017-12826
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729185857
• UDI-Public: 08714729185857
• Combination Product (y/n): N
• Reporter Country Code: CN
• PMA/PMN Number: P900056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/08/2017

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: 03/31/2019
• Device Model Number: H802227680030
• Device Catalogue Number: 22768-003
• Device Lot Number: 0020519290
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/08/2017
• Initial Date FDA Received: 12/21/2017
• Supplement Dates Manufacturer Received: 01/04/2018
• Supplement Dates FDA Received: 01/23/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/13/2017
• 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