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

Model Number 3320

Device Problems Break (1069); Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/28/2020

Event Type  malfunction  

Event Description

It was reported that the device was leaking.The target lesion was located in the chest.A 1.25mm rotalink burr was selected for use in an rotational atherectomy procedure.During procedure, it was noted that the device was leaking liquid and there was a visible crack on the burr catheter.The procedure was completed with another of the same device.No patient complications reported and patient was stable.

Event Description

It was reported that the device was leaking.The target lesion was located in the chest.A 1.25mm rotalink burr was selected for use in an rotational atherectomy procedure.During procedure, it was noted that the device was leaking liquid and there was a visible crack on the burr catheter.The procedure was completed with another of the same device.No patient complications reported and patient was stable.

Manufacturer Narrative

Device evaluated by manufacturer: the returned complaint device consisted of a rotablator burr catheter.The sheath, coil, burr and annulus were microscopically and visually examined.Visual and microscopic examination revealed that the sheath was twisted and separated with a hole.The sheath was twisted 31cm-32.5cm from the strain relief.The sheath was separated 31.5cm from the proximal of the burr.The sheath hole was 31.2cm from the strain relief.Inspection of the remainder of the device presented no other damage or irregularities.

• Brand Name: ROTALINK BURR
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10097507
• MDR Text Key: 193111183
• Report Number: 2134265-2020-07091
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729185864
• UDI-Public: 08714729185864
• Combination Product (y/n): N
• PMA/PMN Number: P900056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/17/2020

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: 07/06/2021
• Device Model Number: 3320
• Device Catalogue Number: 3320
• Device Lot Number: 0024220286
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2020
• Initial Date Manufacturer Received: 05/11/2020
• Initial Date FDA Received: 05/28/2020
• Supplement Dates Manufacturer Received: 07/08/2020
• Supplement Dates FDA Received: 07/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Weight: 70