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

Model Number H749236310020

Device Problems Fluid/Blood Leak (1250); Hole In Material (1293)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the outer shaft on the burr had a small hole and leak occurred.The target lesion was located in the moderately tortuous and moderately calcified proximal left anterior descending artery.A 1.25mm rotalink¿ plus was selected for use.After the procedure, when the burr was changed to a bigger one on the table with ongoing flushing, a small hole on the outer shaft of the burr was noted and was leaking.The procedure was completed with a 1.50mm rotalink¿ plus.No patient complications were reported and patient's status was stable.

Manufacturer Narrative

Device evaluated by manufacturer: the rotalink burr catheter was returned for evaluation as the advancer unit was disposed of at the facility.The handshake connection, sheath, coil and burr were microscopically and visually inspected.Blood was observed in the sheath.Three holes were noted on the sheath at 20cm, 20.2cm and 22.5cm from the strain relief respectively.The holes were consistent with the hemostasis valve being over tightened during the procedure.Functional testing was performed by connecting the rotablator rotalink burr catheter device up to a test advancer and then to the rotablator control console system.When the drip line was turned on, water started leaking from the holes in the sheath.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.The most probable root cause is operational context as device performance was limited due to anatomical procedural factors.(b)(4).

Event Description

It was reported that the outer shaft on the burr had a small hole and leak occurred.The target lesion was located in the moderately tortuous and moderately calcified proximal left anterior descending artery.A 1.25mm rotalink¿ plus was selected for use.After the procedure, when the burr was changed to a bigger one on the table with ongoing flushing, a small hole on the outer shaft of the burr was noted and was leaking.The procedure was completed with a 1.50mm rotalink¿ plus.No patient complications were reported and patient's status was stable.

• 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: 6916934
• MDR Text Key: 89477582
• Report Number: 2134265-2017-09642
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729316411
• UDI-Public: 08714729316411
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: P900056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/12/2017

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: 05/01/2019
• Device Model Number: H749236310020
• Device Catalogue Number: 23631-002
• Device Lot Number: 0020710006
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/12/2017
• Initial Date FDA Received: 10/05/2017
• Supplement Dates Manufacturer Received: 10/09/2017
• Supplement Dates FDA Received: 11/01/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/07/2017
• 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