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

Model Number H749236310020

Device Problem Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/01/2018

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 shaft break occurred.A 1.25mm rotalink¿ plus was selected for use.During preparation, a breakage on the burr sheath about 15cm from the tip was noted.The device was then withdrawn as entire system and classic dilatation was performed.No patient complications were reported.

Event Description

It was further reported that the sheath damage was due to interaction with the hemostasis valve.

Manufacturer Narrative

(b)(4).

• Brand Name: ROTALINK¿ PLUS
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC - MAPLE GROVE; one scimed place; maple grove MN 55311
• MDR Report Key: 7781788
• MDR Text Key: 117150224
• Report Number: 2134265-2018-07220
• Device Sequence Number: 1
• Product Code: MCX
• 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: 07/20/2018

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 Model Number: H749236310020
• Device Catalogue Number: 23631-002
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/20/2018
• Initial Date FDA Received: 08/14/2018
• Supplement Dates Manufacturer Received: 09/17/2018
• Supplement Dates FDA Received: 10/08/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1