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

Model Number 3241

Device Problems Use of Device Problem (1670); Intermittent Loss of Power (4016)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/22/2019

Event Type  malfunction  

Manufacturer Narrative

Initial reporter address: (b)(6).Device evaluated by manufacturer: the device was returned for analysis.The returned complaint device consisted of a rotablator rotalink plus device.The advancer, handshake connections, sheath, coil and burr were microscopically and visually examined.There are numerous sheath kinks.The damaged rotawire was removed with resistance and was sent to coyol cis.Microscopic examination of the device revealed that the annulus was damaged and not rounded.The coil is stretched.Functional testing was performed by connecting the advancer to the rotablator control console system.There were no abnormal noises or leaks and the device did not run; so it was not able to get any speed.The advancer was dismantled and the ultem was found to be melted and the turbine was corroded.Inspection of the remainder of the device presented no other damage or irregularities.

Event Description

Reportable based on device analysis of related rotawire completed on 13mar2019, which indicates that the distal end of the wire was broken.The burr could have been contributed to the event.Vascular access was obtain via femoral artery.The 90%, 28x3.0mm, concentric and de novo target lesion was located in severely calcified left anterior descending artery.During the procedure, the device was loaded on rota floppy wire.Subsequently, the rpm was getting lower due to heavy calcium in the lesion and the device stalled.No separation was noted on the device.The procedure was completed with another of the same device.No complications reported and patient is stable.However, device analysis revealed that the distal end was broken.

• 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: 8483946
• MDR Text Key: 140942775
• Report Number: 2134265-2019-03467
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729228363
• UDI-Public: 08714729228363
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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: 04/04/2019

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: 01/31/2019
• Device Model Number: 3241
• Device Catalogue Number: 3241
• Device Lot Number: 0020268800
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/13/2019
• Initial Date FDA Received: 04/04/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/14/2017
• 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
• Patient Age: 45 YR
• Patient Weight: 56