MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM; CATHETER, CORONARY, ATHERECTOMY

Model Number UNK508

Device Problem Device Damaged by Another Device (2915)

Patient Problems Death (1802); Ventricular Tachycardia (2132)

Event Date 12/01/2011

Event Type  Death  

Manufacturer Narrative

Device evaluated by manufacturer: it is indicated that the device will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.The batch number is unknown and the manufacturing records for the complaint device could not be reviewed.The most probable root cause is operational context as device performance was limited due to anatomical procedural factors.(b)(4).

Event Description

Same case as mdr id: 2134265-2017-03080.It was reported that an unknown guidewire fractured, the patent later experienced ventricular tachycardia and expired.The patient underwent an atherectomy procedure in (b)(6) 2011 to treat angina pectoris.Rotational atherectomy was performed with the use of a rotablator rotational atherectomy system, a rotawire, and an unknown ¿protect wire.¿ during use, this unknown ¿protect wire¿ became detached.The patient was transported to another hospital in order to remove the detached wire fragment.Four days later, the patient experienced ventricular tachycardia and subsequently expired.

• Brand Name: ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC - MAPLE GROVE; one scimed place; maple grove MN 55311
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 6479534
• MDR Text Key: 72327863
• Report Number: 2134265-2017-02953
• Device Sequence Number: 1
• Product Code: MCX
• 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
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 03/17/2017

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: UNK508
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/17/2017
• Initial Date FDA Received: 04/11/2017
• 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
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death