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

Model Number H749236310030

Device Problem Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/17/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluated by mfr: 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 there was a hole in the burr catheter.The target lesion was located in the right coronary artery (rca).A 1.50mm rotalink¿ plus was selected for use.During procedure, it was noted that there was a hole in the catheter and fluid was spraying through the pinhole.The device was removed from the patient's body.The procedure was completed with another of the same burr.No patient complications were reported and the patient's status is fine.

Manufacturer Narrative

Device evaluated by manufacturer: the device was returned for evaluation.The advancer, handshake connections, sheath, coil, and burr were microscopically and visually inspected.A kink with a hole in the sheath 19cm distal of the strain relief was noted.Functional testing was performed by connecting the device to the rotablator control console system.When the drip line was turned on, water started leaking from the hole in the sheath.The rotablator system was tested and there were no abnormal noises and the device did not run; so it wasn¿t able to get any speed.The advancer was dismantled and the turbine was found to be corroded and the ultem was found to be melted.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.The most probable root cause is considered handling damage as the event occurred without direct patient contact.(b)(4).

Event Description

It was reported that there was a hole in the burr catheter.The target lesion was located in the right coronary artery (rca).A 1.50mm rotalink¿ plus was selected for use.During procedure, it was noted that there was a hole in the catheter and fluid was spraying through the pinhole.The device was removed from the patient's body.The procedure was completed with another of the same burr.No patient complications were reported and the patient's status is fine.

• 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: 6484861
• MDR Text Key: 72502295
• Report Number: 2134265-2017-03336
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729228363
• UDI-Public: (01)08714729228363(17)20181231(10)20211158
• 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
• Report Date: 03/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2018
• Device Model Number: H749236310030
• Device Catalogue Number: 23631-003
• Device Lot Number: 20211158
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/27/2017
• 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