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

Model Number H749236310020

Device Problem Difficult to Remove (1528)

Patient Problems Low Blood Pressure/ Hypotension (1914); Thrombosis (2100)

Event Date 03/23/2018

Event Type  Injury  

Manufacturer Narrative

Age at the time of event: 18 years or older (b)(4).

Event Description

Same case as mdr id: 2134265-2018-04058.It was reported that the patient's blood pressure went down and removal difficulties occurred.The target lesion was located in the right coronary artery.A 1.25mm rotalink¿ plus and a 330cm rotawire were selected for use.During procedure, the physician encountered difficulty in crossing the rotawire.Subsequently, the rotawire was able to cross the lesion and the burr was loaded.However, the patient's blood pressure started to go down; thus, the physician aspirated the vessel and the blood flow was resolved.The burr was again advanced to the patient's body; however, the burr became stuck in the guide catheter around the secondary curve.The physician maneuvered the burr by pushing and pulling a few times and activate the dynaglide mode to facilitate advancement.The burr was advanced but resistance was still encountered and it kept ejecting the guide catheter out.Thus, it was decided to discontinue the procedure.It was noted that the burr was difficult to remove so the rotawire and the burr were removed as a unit.Thrombus was observed twirled around the rotawire upon removal.There were no further patient complications reported and the patient's condition was stable.

Manufacturer Narrative

Device evaluated by manufacturer: the device was returned for analysis.The returned product consisted of the rotablator rotalink plus device with the rotawire for the related complaint.Visual and microscopic examination of the advancer, handshake connections, coil, sheath, and burr were performed and revealed that the coil was kinked at the handshake connection.There was foreign matter on the tip of the rotawire device that matches thrombus.Functional testing was performed by inserting the rotawire into the burr and advancing through the burr catheter; however, the rotawire stopped at the kinked coil and was unable to advance.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.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: 2134265-2018-04058.It was reported that the patient's blood pressure went down and removal difficulties occurred.The target lesion was located in the right coronary artery.A 1.25mm rotalink plus and a 330cm rotawire were selected for use.During procedure, the physician encountered difficulty in crossing the rotawire.Subsequently, the rotawire was able to cross the lesion and the burr was loaded.However, the patient's blood pressure started to go down; thus, the physician aspirated the vessel and the blood flow was resolved.The burr was again advanced to the patient's body; however, the burr became stuck in the guide catheter around the secondary curve.The physician maneuvered the burr by pushing and pulling a few times and activate the dynaglide mode to facilitate advancement.The burr was advanced but resistance was still encountered and it kept ejecting the guide catheter out.Thus, it was decided to discontinue the procedure.It was noted that the burr was difficult to remove so the rotawire and the burr were removed as a unit.Thrombus was observed twirled around the rotawire upon removal.There were no further patient complications reported and the patient's condition 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: 7516699
• MDR Text Key: 108351291
• Report Number: 2134265-2018-04059
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729316411
• UDI-Public: 08714729316411
• Combination Product (y/n): N
• Reporter Country Code: SG
• 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: 04/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/29/2019
• Device Model Number: H749236310020
• Device Catalogue Number: 23631-002
• Device Lot Number: 21062702
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/20/2018
• Initial Date FDA Received: 05/15/2018
• Supplement Dates Manufacturer Received: 05/17/2018
• Supplement Dates FDA Received: 06/06/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/04/2017
• 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 Outcome(s): Required Intervention