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

Model Number H802227680030

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

Patient Problems Death (1802); Occlusion (1984); Thrombus (2101)

Event Date 11/18/2013

Event Type  Death  

Event Description

It was reported that during a rotational atherectomy procedure, venous shutdown occurred and the patient expired.Vascular access was obtained through the right femoral artery.The target lesion was located in the calcified proximal to mid left anterior descending artery (lad).A 1.5mm rotalink burr was used to ablate the lad.Venous shutdown occurred in the lad, ramus and the circumflex possibly due to thrombus.The physician performed multiple attempts to balloon and stent the vessels but the patient expired.It was noted the patient was on angiomax for the procedure and maximum antiplatelet treatment for many days prior to procedure.

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.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: ingrid matte ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 3568047
• MDR Text Key: 4048723
• Report Number: 2134265-2013-09527
• 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: 12/11/2013

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 Expiration Date: 01/31/2015
• Device Model Number: H802227680030
• Device Catalogue Number: 22768-003
• Device Lot Number: 15850145
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/11/2013
• Initial Date FDA Received: 01/10/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/06/2013
• 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
• Patient Age: 57 YR