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

Model Number H802227680020

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/28/2018

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: under 18 years old.(b)(4).

Event Description

It was reported that the rotational speed was unstable.A 1.25mm rotalink¿ burr was selected for use.During procedure, it was noted that the burr handshake connection could not connect to the advancer; which resulted to unstable rotational speed.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.

Event Description

It was reported that the rotational speed was unstable.A 1.25mm rotalink¿ burr was selected for use.During procedure, it was noted that the burr handshake connection could not connect to the advancer; which resulted to unstable rotational speed.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.

Manufacturer Narrative

Device evaluated by mfr: the device was returned for analysis.The handshake, coil, sheath, and burr were microscopically and visually inspected.The handshake connection was pulled in the sheath with the coil prolapsed at the distal end preventing movement of the handshake and connection to the advancer.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.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).

• 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
• MDR Report Key: 7626915
• MDR Text Key: 112088434
• Report Number: 2134265-2018-05483
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729185864
• UDI-Public: 08714729185864
• Combination Product (y/n): N
• PMA/PMN Number: P900056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 05/29/2018

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: 05/27/2019
• Device Model Number: H802227680020
• Device Catalogue Number: 22768-002
• Device Lot Number: 20813775
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2018
• Initial Date Manufacturer Received: 05/29/2018
• Initial Date FDA Received: 06/21/2018
• Supplement Dates Manufacturer Received: 06/28/2018
• Supplement Dates FDA Received: 07/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1