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

Model Number 3320

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/26/2019

Event Type  malfunction  

Event Description

It was reported that the catheter broke.A 1.50mm rotalink burr and a rotalink advancer was selected for use.During the procedure, when advancing the burr in the patient's body the catheter and the advancer were fractured.It was confirmed that the external part of the catheter was fractured, and the device that was left in the patient was pulled out directly and there were no device fragment's left inside the patient's body.The procedure was complete with another of the same device.No patient complications were reported and the patient was stable.

Manufacturer Narrative

Device evaluated by the manufacturer:the device was returned for analysis.There is blood in the entire length of the sheath.The handshake connection, sheath, coil, burr and annulus were microscopically and visually examined.The presence of blood indicates that there was no sufficient flow of saline during the usage of the device.The handshake connection was not visible and would not retract, the housing was removed revealing that the handshake connection is stuck in the sheath.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.Inspection of the remainder of the device presented no other damage or irregularities.

Event Description

It was reported that the catheter broke.A 1.50mm rotalink burr and a rotalink advancer was selected for use.During the procedure, when advancing the burr in the patient's body the catheter and the advancer were fractured.It was confirmed that the external part of the catheter was fractured, and the device that was left in the patient was pulled out directly and there were no device fragment's left inside the patient's body.The procedure was complete with another of the same device.No patient complications were reported and the patient was stable.

• 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: 8905990
• MDR Text Key: 154746710
• Report Number: 2134265-2019-09908
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729185857
• UDI-Public: 08714729185857
• 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: 09/19/2019

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: 10/19/2020
• Device Model Number: 3320
• Device Catalogue Number: 3320
• Device Lot Number: 0022958386
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2019
• Initial Date Manufacturer Received: 07/29/2019
• Initial Date FDA Received: 08/19/2019
• Supplement Dates Manufacturer Received: 08/30/2019
• Supplement Dates FDA Received: 09/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Weight: 51