MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ROTALINK PLUS; CATHETER, CORONARY, ATHERECTOMY

Model Number 3241

Device Problem Use of Device Problem (1670)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/26/2019

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: 18 years or older.Device evaluated by mfr: the device was returned for analysis.The returned complaint device consisted of a rotablator rotalink plus device.The advancer unit and burr catheter were received together.The handshake connection, sheath, coil, burr and annulus were microscopically and visually examined.The sheath is completely torn/separated in 3 locations: 98.4cm from the strain relief, 100.2cm from the strain relief and 107.3cm from the strain relief.Microscopic examination of the device revealed that the annulus was damaged and not rounded which is consistent with damage seen with the use of a rotawire.The coil is stretched.Functional testing was performed by connecting the advancer to the rotablator control console system.The rotablator system was able to reach optimum speed with no issues.Inspection of the remainder of the device presented no other damage or irregularities.There was no evidence of any damage or irregularities contributing to the reported difficulty, which could not be confirmed because the clinical circumstances could not be replicated.

Event Description

Reportable based on device analysis completed on 09-may-2019.It was reported that the device was unable to cross the lesion.A 1.75mm rotalink plus was selected for use.During the procedure, it was noted that the device was unable to cross the lesion.The procedure was completed with a different device.No patient complications were reported.However, device analysis revealed that the sheath is completely torn/separated in 3 locations: 98.4cm from the strain relief, 100.2cm from the strain relief and 107.3cm from the strain relief.

• Brand Name: ROTALINK PLUS
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORK LIMITED; cork business technology park; model farm road; cork ; EI
• Manufacturer Contact: sonali arangil ; two scimed place; maple grove, MN 55311 ; 6515827403
• MDR Report Key: 8646067
• MDR Text Key: 146237608
• Report Number: 2134265-2019-05936
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729228370
• UDI-Public: 08714729228370
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P900056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/28/2019

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: 11/04/2019
• Device Model Number: 3241
• Device Catalogue Number: 3241
• Device Lot Number: 0021464687
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/09/2019
• Initial Date FDA Received: 05/28/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/04/2017
• 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