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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 H7493892820200
Device Problem Kinked (1339)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/03/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Device evaluated by mfr: returned product consisted of a maverick 2 balloon catheter. The balloon was loosely folded. The outer shaft, inner shaft, balloon and tip were microscopically examined. The tip is damaged. The hypotube is kinked 68. 5cm from the hub. The balloon has a 21mm longitudinal tear starting at the proximal balloon waist. Inspection of the remainder of the device presented no other damage or irregularities. There was no evidence of any material or manufacturing deficiencies contributing to the damage. The investigation conclusion is operational context as the product meets the design & manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited. (b)(4).
 
Event Description
Reportable based on device analysis completed on 28-may-2018. It was reported that shaft kink occurred. The 90% stenosed, 20x2. 0mm target lesion was located in the moderately tortuous and calcified left anterior descending artery. A 2. 00mm x 20mm maverick²¿ balloon catheter was advanced for dilatation. However, it was noted that the shaft was kinked 25cm away from the physician's hand. The procedure was completed with a different device. No patient complications were reported and the patient's status was stable. However, returned device analysis revealed balloon longitudinal tear.
 
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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 Key7615957
MDR Text Key111559677
Report Number2134265-2018-05325
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeCN
PMA/PMN Number
P860019
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation
Type of Report Initial
Report Date 05/28/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/19/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/03/2020
Device Model NumberH7493892820200
Device Catalogue Number38928-2020
Device Lot Number0020970654
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/09/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/28/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/04/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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