MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE MAVERICK²¿; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

Model Number H7493892820300

Device Problems Break (1069); Deflation Problem (1149)

Patient Problems Cardiac Arrest (1762); Cardiopulmonary Arrest (1765); Death (1802); Myocardial Infarction (1969); Thrombosis (2100); Discomfort (2330); Device Embedded In Tissue or Plaque (3165)

Event Date 08/08/2017

Event Type  Death  

Manufacturer Narrative

(b)(6).(b)(4).

Event Description

Same case as mdr id# 2134265-2017-08982.It was reported that a balloon failed to deflate and the shaft broke.A piece was not retrieved from the patient.The patient experienced thrombosis, myocardial infarction and died six days post procedure.The patient was admitted to the hospital and three days later, percutaneous coronary intervention (pci) was performed.The target lesion was in-stent restenosis of a previously implanted taxus liberte stent in the right circumflex artery (rcx).A maverick²¿ balloon catheter was advanced to pre-dilate the vessel.The balloon expanded well, but could not be deflated again so this physician pulled a couple of times on the balloon and the distal 17cm of the shaft (with the balloon) ripped off.The distal, sill inflated part of the balloon was partially fixated behind the existing stent.The balloon could not be recovered and was held in place using a distally placed stent.The procedure was completed with a different device.The patient was stable with a timi 3.An ultrasound was performed to see if he could find anything else in the vessel.The physician couldn¿t see anything.The physician recommended that the patient contact a heart surgeon for a second opinion.The patient rejected.The patient had no other discomfort and was therefore discharged two days post procedure.One day later the patient came back due to unclear discomfort.The patient was admitted and stayed under hospital supervision.A stress electrocardiogram (ecg) was performed and following the test the patient told the physician that he feet an unease and collapsed.The patient was reanimated and afterward was sent for repeat pci.Thrombus was found proximal and distal to the previously treated lesion in the rcx.Thrombus in the ramus inter-ventricularis anterior (riva) was also suspected.Ballooning and aspiration were performed.The patient had timi i flow in riva and timi i flow in rcx.The patient went into cardiac arrest and after more than 3 hours resuscitation, the patient died due to myocardial infarction.

Manufacturer Narrative

Device evaluated by mfr: returned product consisted of a maverick 2 balloon catheter without the distal shaft and balloon.124cm of the shaft, hypotube and the hub were returned.The hypotube was microscopically examined.The shaft was separated 124cm from the hub and the distal portion of the catheter was not returned.There was no evidence of any material or manufacturing deficiencies contributing to the damage.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.A review of the procedural cine was performed.The images provided are consistent with the reported complaint of no-deflate, stuck-on-stent and balloon shaft separation.The images are also consistent with the reported patient death; however, a massive aortic dissection was likely responsible for the patient death since the no-deflate appeared to be adequately managed.Evidence of the dissection was present before the maverick or any interventional equipment entered the patient's body.Operations engineering personnel reviewed the applicable manufacturing records related to the complaint device.It was confirmed that the devices in this batch met all applicable specifications.The most probable root cause is operational context as device performance was limited due to anatomical procedural factors.(b)(4).

Event Description

Additional information identified an aortic dissection was present before the maverick 2 or any interventional equipment entered the patient¿s body.

• Brand Name: MAVERICK²¿
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• 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: 6843626
• MDR Text Key: 84915451
• Report Number: 2134265-2017-08500
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• PMA/PMN Number: P860019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/18/2020
• Device Model Number: H7493892820300
• Device Catalogue Number: 38928-2030
• Device Lot Number: 20787390
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/07/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/21/2017
• 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; Hospitalization; Required Intervention
• Patient Age: 51 YR