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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION MAVERICK; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
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BOSTON SCIENTIFIC CORPORATION MAVERICK; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS Back to Search Results
Model Number 7585
Device Problems Break (1069); Entrapment of Device (1212)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/24/2019
Event Type  malfunction  
Event Description
It was reported that shaft break and catheter entrapment occurred.The target lesion was located in the right coronary artery.After a guidewire crossed the lesion, a 2.00mm x 15mm maverick balloon catheter was advanced for dilatation.However, during the procedure, the balloon delivery shaft was fractured and bundled with the guidewire.The device was completely removed from the patient without any intervention.The procedure was completed with another of the same device.There were no patient complications reported and the patient's status was stable.
 
Event Description
It was reported that shaft break and catheter entrapment occurred.The target lesion was located in the right coronary artery.After a guidewire crossed the lesion, a 2.00mm x 15mm maverick balloon catheter was advanced for dilatation.However, during the procedure, the balloon delivery shaft was fractured and bundled with the guidewire.The device was completely removed from the patient without any intervention.The procedure was completed with another of the same device.There were no patient complications reported and the patient's status was stable.
 
Manufacturer Narrative
D4 lot number corrected from 0024119905 to 0024037186.D4 expiration date corrected from 07/16/2022 to 06/30/2022.H4 device manufactured date corrected from 07/17/2019 to 07/01/2019.Returned product consisted of a maverick 2 balloon catheter.The balloon was tightly folded.There were numerous hypotube kinks.The hypotube was separated 36.5cm from the hub.The separated ends of the hypotube was ovaled indicating the hypotube was kinked prior to separating.The product mandrel that was in the wire lumen was able to be removed without any difficulty.
 
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Brand Name
MAVERICK
Type of Device
CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key9603682
MDR Text Key178039913
Report Number2134265-2020-00167
Device Sequence Number1
Product Code LOX
UDI-Device Identifier08714729370062
UDI-Public08714729370062
Combination Product (y/n)N
PMA/PMN Number
P860019
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup
Report Date 02/27/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/17/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/30/2022
Device Model Number7585
Device Catalogue Number7585
Device Lot Number0024037186
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/23/2020
Date Manufacturer Received02/07/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age68 YR
Patient Weight75
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