MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY FLEXTOME® CUTTING BALLOON®; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

Model Number H749CBM3200060

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

Patient Problems Death (1802); Obstruction/Occlusion (2422)

Event Date 08/12/2016

Event Type  Death  

Manufacturer Narrative

(b)(4) 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).

Event Description

Same case as mdr id: 2134265-2016-08102, same case as mdr id: 2134265-2016-08103, same case as mdr id: 2134265-2016-08104, same case as mdr id: 2134265-2016-08105, same case as mdr id: 2134265-2016-08106.It was reported a plaque shift occurred and the patient expired.The patient presented with chest pain as a non stemi.The target lesion was located in the first obtuse marginal branch (omb).The physician wanted to perform an intravascular ultrasound (ivus) on the first omb and the proximal circumflex.A 182cm choice pt guidewire was advanced in the first omb; an ivus catheter was unable to advance through omb.A non-bsc balloon was advanced through the omb and inflated with residual waste on the balloon.The physician then advanced a flextome cutting balloon through the first omb but was unable to cross the lesion successfully.The cutting balloon was removed and a 1.2mm x 12mm threader balloon was advanced and inflated successfully.As the threader balloon was being removed, the guide catheter lost position and pulled the balloon and wire out of the left main.The guide catheter was reinserted and an angiogram noted that the circumflex closed.After multiple guidewires (choice pt and pt graphix) were used in an attempt to gain access to the circumflex (trying to re-establish flow), one was able to be advanced to the distal circumflex and a non-bsc balloon was used in the proximal circumflex.The patient then became hypotensive and nonresponsive.An unknown stent was placed in the proximal circumflex.The patient coded and resuscitation was performed.An angiogram was obtained.Timi2 flow was visualized with haziness distal to the implanted stent and a plaque shift was noted in the distal left main.The stent delivery device was re-advanced to the distal left main and was inflated as well as distal to the stent.Another angiogram was taken.A ventricular assist device (vad) was placed as cardiopulmonary resuscitation (cpr) was being performed but the patient expired.

• Brand Name: FLEXTOME® CUTTING BALLOON®
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY
• Manufacturer Contact: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 5935797
• MDR Text Key: 54173876
• Report Number: 2134265-2016-08101
• Device Sequence Number: 1
• Product Code: NWX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P950020
• 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: 08/12/2016

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: 09/06/2018
• Device Model Number: H749CBM3200060
• Device Catalogue Number: CBM320006
• Device Lot Number: 0018374979
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/12/2016
• Initial Date FDA Received: 09/08/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/18/2015
• 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: 73 YR