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

Model Number UNK553

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Embolism (1829)

Event Date 02/13/2017

Event Type  Injury  

Manufacturer Narrative

Device evaluated by mfr: it is indicated that the device will not be returned for evaluation.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).

Event Description

It was reported that an embolism occurred.The target lesions were located in the left superficial femoral artery (sfa), anterior tibial artery, and branches.A rotablator rotational atherectomy system was used for an atherectomy procedure.The device stopped working in the middle of the procedure.It would not advance any further and sounded like it stalled out.The device was removed from the patient and the procedure was completed with a non-bsc device.After the procedure, the patient's leg was cold which was treated with balloon angioplasty.Angiography revealed an embolism which was thought to be plaque.The patient returned to the hospital and an angiogram was performed.No further treatment was performed as the patient had enough collaterals.The patient is currently stable.

• 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: 6421702
• MDR Text Key: 70488900
• Report Number: 2134265-2017-02099
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/24/2017

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?: No
• Device Operator: Health Professional
• Device Model Number: UNK553
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/24/2017
• Initial Date FDA Received: 03/21/2017
• 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): Other