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

Model Number H749236310040

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).Device evaluated by manufacturer: returned product consisted of the rotalink burr catheter for the complaint device; however, the advancer was not returned for analysis.The handshake connection, sheath, coil, and burr were microscopically and visually inspected.The sleeve portion of the handshake connection was pinched and detached.The detached portion was not returned for analysis.The sheath was torn 21.5cm distal of the strain relief.The damage to the sheath is consistent with damage being cause by the device being over-tightened by the hemostasis valve and then twisted/pulled.The rotawire used in the procedure was not returned for analysis, so a test rotawire was used.The wire was advanced through the burr up to the handshake connection; however, the wire couldn¿t pass due to the broken sleeve.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).

Event Description

It was reported that saline leak was observed.The target lesion was located in the coronary artery.A 1.75mm rotalink plus was selected for use.The physician loaded the burr over the rotawire proximal to the lesion.When ablation was performed, it was noticed that there was difficulty in moving the burr as there was no saline drip at the side of the burr.Furthermore when the rotaburr was retracted, it was noted that there was drip coming about 20cm proximal from the burr from a hole in the catheter.The device was removed in dynaglide mode.The procedure was completed with another of the same device.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: 7249181
• MDR Text Key: 99790616
• Report Number: 2134265-2018-00804
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729228370
• UDI-Public: 08714729228370
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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
• Report Date: 01/18/2018

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: 09/23/2019
• Device Model Number: H749236310040
• Device Catalogue Number: 23631-004
• Device Lot Number: 21287930
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/18/2018
• Initial Date FDA Received: 02/07/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/23/2017
• 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