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

Model Number H802227680040

Device Problem Entrapment of Device (1212)

Patient Problems Cardiac Arrest (1762); Ventricular Tachycardia (2132)

Event Date 11/14/2014

Event Type  Injury  

Event Description

It was reported that a burr became stuck on the lesion.The target lesion was located in the left anterior descending (lad) artery.A 1.75mm rotalink¿ burr was selected to treat the lesion.During procedure, it was observed that the burr lodged in the lad.The physician vasodilated the vessel, however it was noted that the patient went into arrest.The device was then pulled out from the patient.The patient then went into ventricular tachycardia, defibrillation was done to the patient and the patient¿s condition was fine thereafter.There were no further patient complications reported.

Manufacturer Narrative

(b)(4).Age at time of event: 18 years or older.(b)(4).Device evaluated by mfr.: it is indicated that the device will not be returned for evaluation; therefore a failure analysis of the complaint device could not be completed.A review of the batch history, historical trending, and similar complaint trending review for the product family will be conducted.If there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).

• Brand Name: ROTALINK? BURR
• 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: 4318223
• MDR Text Key: 5129080
• Report Number: 2134265-2014-07630
• 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: Physician
• Type of Report: Initial
• Report Date: 11/18/2014

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 Model Number: H802227680040
• Device Catalogue Number: 22768-004
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/18/2014
• Initial Date FDA Received: 12/10/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention