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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC - MAPLE GROVE MAVERICK²¿ CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS Back to Search Results
Model Number H7493892815250
Device Problem Material Rupture (1546)
Patient Problems Death (1802); Electro-Mechanical Dissociation (1826); Pulmonary Edema (2020); Rupture (2208)
Event Date 03/21/2017
Event Type  Death  
Manufacturer Narrative
(b)(4). 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 balloon rupture, vessel rupture and patient death occurred. The target lesion was located in the circumflex artery. A 2. 50mm x 15mm maverick²¿ balloon catheter was advanced in the first marginal for pre-dilation. The balloon was initially inflated at 18 atmospheres for 37 seconds. However, on the second inflation at 12 atmospheres, the balloon ruptured and the whole circumflex artery ruptured. Two non-bsc stents were then implanted immediately, but the patient's status degraded despite reestablishing a normal flow. Subsequently, the patient developed pulmonary edema and electromechanical dissociation. After 1 hour and 30 minutes of resuscitation, the patient died.
 
Manufacturer Narrative
(b)(4).
 
Event Description
It was further reported that no autopsy was performed. The 2. 5mm x 15mm maverick balloon was inflated 2 times for a total of 37 seconds at 18 atm for predilation in the first marginal. The balloon ruptured on the third inflation in the circumflex artery at 12 atm, not the second inflation as previously reported.
 
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Brand NameMAVERICK²¿
Type of DeviceCATHETERS, 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 Key6457177
MDR Text Key71632023
Report Number2134265-2017-03592
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
P860019
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/28/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/04/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/29/2020
Device Model NumberH7493892815250
Device Catalogue Number38928-1525
Device Lot Number20244779
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/11/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/06/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 04/04/2017 Patient Sequence Number: 1
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