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

Model Number H749236310030

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problems Intimal Dissection (1333); Death (1802); Extravasation (1842); Cardiac Tamponade (2226)

Event Date 06/06/2014

Event Type  Death  

Event Description

It was reported that death occurred.The target lesion was located in a calcified vessel.A 1.5mm rotalink¿ plus was advanced to treat the target lesion; however, the burr became lodged in the lesion.Upon attempting to pull back the burr manually, the shaft broke at the burr.The burr was stull on the rotawire and stuck in the lesion, but the shaft disconnected and was able to be pulled back out of the patient.A non-bsc catheter was used to retrieve the burr and rotawire from the patient.No issue was noted with the rotawire.The physician elected to end the procedure and reschedule the patient for another rotational atherectomy procedure the following day.No patient complications were reported and the patient's condition was listed as fine a few hours later, the patient died.

Event Description

It was reported that death occurred.The target lesion was located in a calcified vessel.A 1.5mm rotalink¿ plus was advanced to treat the target lesion; however, the burr became lodged in the lesion.Upon attempting to pull back the burr manually, the shaft broke at the burr.The burr was stull on the rotawire and stuck in the lesion, but the shaft disconnected and was able to be pulled back out of the patient.A non-bsc catheter was used to retrieve the burr and rotawire from the patient.No issue was noted with the rotawire.The physician elected to end the procedure and reschedule the patient for another rotational atherectomy procedure the following day.No patient complications were reported and the patient's condition was listed as fine a few hours later, the patient died.

Event Description

Same case as user voluntary medwatch (b)(4).It was further reported that in the process of retrieving the burr from the coronary artery, a dissection occurred causing extravasation and cardiac tamponade.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Device evaluated by mfr: a visual examination revealed the handshake connection was inspected and no damage was noted.There was no burr attached to the distal end of the coil.There was evidence of adhesive on the coil to confirm that the burr was attached to the coil during the manufacturing process.Upon further investigation of the coil it was observed that the coil was stretched and broken confirming that the burr was detached as a result of the coil being pulled with force in an attempt to remove the burr from the lesion.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable rootcause is operational context as device performance was limited due to anatomical procedural factors.(b)(4).

Manufacturer Narrative

(b)(4).

• 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: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 3909141
• MDR Text Key: 4488776
• Report Number: 2134265-2014-03868
• Device Sequence Number: 1
• Product Code: MCX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P900056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2016
• Device Model Number: H749236310030
• Device Catalogue Number: 23631-003
• Device Lot Number: 0016839000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/01/2014
• Initial Date FDA Received: 07/02/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 09/29/2014; 10/27/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/31/2014
• 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 Outcome(s): Death; Required Intervention