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

Model Number H749236310020

Device Problems Entrapment of Device (1212); Infusion or Flow Problem (2964)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/17/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that blood backed up in the burr.The target lesion was located in the left anterior descending (lad) artery.A 1.25mm rotalink¿ plus and a rotawire were selected for use.During procedure, it was noted that the rotaglide stopped running through the burr.Furthermore, blood backed up into the burr and the burr failed to advance.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was fine.However, device analysis revealed that the rotawire was unable to be removed from the burr.

Manufacturer Narrative

Device evaluated by manufacturer: returned product consisted of the rotalink burr catheter for the complaint device; however, the advancer for the complaint was not returned.Following analysis, the handshake connection, sheath, coil, and burr were microscopically and visually inspected.There was blood in the sheath.The annulus of the burr was flared, damaged, and not rounded.The damage to the annulus is consistent with damage caused by the rotating burr coming into contact with the guidewire during use, leading to the damaged annulus.An attempt to remove the rotawire was unsuccessful.The burr and wire were soaked for 5 minutes in hot water and the devices were still unable to be separated.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.The investigation conclusion is operational context as the product meets the design & manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited.(b)(4).

Event Description

Same case as mdr id: 2134265-2017-12804.It was further reported that the burr became stuck on the rotawire.

Manufacturer Narrative

(b)(4).

Event Description

Same case as mdr id: 2134265-2017-12804.It was further reported that the burr became stuck on the rotawire.

• 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: 7122743
• MDR Text Key: 95463234
• Report Number: 2134265-2017-11997
• Device Sequence Number: 1
• Product Code: MCX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P900056
• 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,Followup
• Report Date: 11/17/2017

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: 06/18/2019
• Device Model Number: H749236310020
• Device Catalogue Number: 23631-002
• Device Lot Number: 0020899820
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/17/2017
• Initial Date FDA Received: 12/15/2017
• Supplement Dates Manufacturer Received: 12/11/2017; 12/11/2017
• Supplement Dates FDA Received: 01/09/2018; 01/10/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/19/2017
• 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: 73 YR