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

Model Number H749236310020

Device Problems Leak/Splash (1354); Split (2537)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/14/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that sheath split and saline leak occurred.The target lesion was located in the heavily calcified left anterior descending artery (lad).A 1.25mm rotalink plus was selected for use.During the procedure, the lining inside the sheath split, the device leaked and resistance was noticed.The procedure was completed with a different device.No patient complications reported and the patient's condition was fine.

Manufacturer Narrative

Device evaluated by mfr., eval summary attached, method codes, result codes, conclusion codes updated.Device evaluated by manufacturer: the device was returned for analysis.The unit was returned with a guide wire running through the device.The guide wire was able to be removed from the device without issue.The unit was returned with blood present in the catheter sheath.A visual examination of the complaint unit was carried out, the advancer knob was locked upon return in a backward position; it was loosened and advanced in order to inspect the handshake connection.The handshake connection was inspected and no damage was noted.A handshake connection test was attempted to examine the integrity of the connection.No issues were noted.Tightened marks were noted on the sheath where the hemostasis valve was tightened.An attempt was made to wet test the device and the sheath leaked approximately 19cm and 21cm from the strain relief.The catheter sheath was examined and was noted to be torn 21cm from the strain relief.The coil was noted to be stretched where the sheath was torn.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 condition of the returned device is consistent with over tightening of the hemostasis valve.The dfu states that ¿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 sheath split and saline leak occurred.The target lesion was located in the heavily calcified left anterior descending artery (lad).A 1.25mm rotalink¿ plus was selected for use.During the procedure, the lining inside the sheath split, the device leaked and resistance was noticed.The procedure was completed with a different device.No patient complications reported and the patient's condition 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: 5217921
• MDR Text Key: 31139314
• Report Number: 2134265-2015-07619
• 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: 10/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2017
• Device Model Number: H749236310020
• Device Catalogue Number: 23631-002
• Device Lot Number: 18149186
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/13/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/02/2015
• 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 Age: 71 YR