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

Model Number H749236310030

Device Problems Fluid/Blood Leak (1250); Device Damaged Prior to Use (2284)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/09/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that a sheath leaked.A 1.50mm rotalink plus was attempted to prep for use.When it was hooked up to the flush solution, a small fluid leak in the plastic shaft portion of the catheter proximal to where it is supposed to come out.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was fine.

Manufacturer Narrative

Device evaluated by manufacturer: the device was returned for analysis.The handshake connection was inspected and no damage was noted.A handshake connection test was attempted to examine the integrity of the connection and no issues were noted.The sheath was noted to be damaged.An attempt was made to functionally wet test using a test rotablator advancer unit.It was noted that water was leaking from the sheath of the device due to a split in the catheter sheath.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause has been determined to be use/user error as the dfu states: "if the hemeostasis valve is tightened excessively, it can crush the sheath around the drive shaft and cause permanent damage to the rotalink catheter.The hemeostasis valve should be closed just tight enough to prevent blood loss, but still allow the rotalink sheath to slide through the valve".(b)(4).

Event Description

It was reported that a sheath leaked.A 1.50mm rotalink¿ plus was attempted to prep for use.When it was hooked up to the flush solution, a small fluid leak in the plastic shaft portion of the catheter proximal to where it is supposed to come out.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was 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: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 5706191
• MDR Text Key: 46800261
• Report Number: 2134265-2016-04714
• 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
• Report Date: 05/10/2016

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: 01/31/2018
• Device Model Number: H749236310030
• Device Catalogue Number: 23631-003
• Device Lot Number: 0018923690
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/10/2016
• Initial Date FDA Received: 06/08/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/13/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/16/2016
• 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