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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 H7493892815200
Device Problems Break (1069); Device Damaged Prior to Use (2284)
Patient Problem No Patient Involvement (2645)
Event Date 03/23/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that shaft break occurred. During unpacking of a 2. 00mm x 15mm maverick²¿ balloon catheter, it was noted that the device delivery shaft was fractured. The procedure was completed with a different device. No patient complications were reported and the patient's status was stable.
 
Manufacturer Narrative
Device evaluated by mfr. , eval summary attached, method codes, result codes, and conclusion codes updated. Device evaluated by mfr. : returned product consisted of a maverick 2 balloon catheter with no other devices. The shaft was examined. The hypotube was completely separated 76. 5cm from the hub. The hypotube fracture surfaces were ovaled, which suggests the device was kinked prior to separation. There were numerous kinks throughout the hypotube. The tip was damaged. The guidewire exit notch was damaged, the damage is consistent with interaction with the product mandrel or guidewire. The investigation conclusion is handling damage as the complaint was caused by handling of the device or portion of the device without direct patient contact. (b)(4).
 
Event Description
It was reported that shaft break occurred. During unpacking of a 2. 00mm x 15mm maverick²¿ balloon catheter, it was noted that the device delivery shaft was fractured. The procedure was completed with a different device. No patient complications were reported and the patient's status was stable.
 
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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 Key7453800
MDR Text Key106273148
Report Number2134265-2018-03317
Device Sequence Number1
Product Code LOX
UDI-Device Identifier08714729370062
UDI-Public08714729370062
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,Followup
Report Date 03/29/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/24/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/17/2020
Device Model NumberH7493892815200
Device Catalogue Number38928-1520
Device Lot Number21525810
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/08/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/30/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/18/2017
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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