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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION QUANTUM MAVERICK CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

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BOSTON SCIENTIFIC CORPORATION QUANTUM MAVERICK CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS Back to Search Results
Model Number 7010
Device Problem Material Integrity Problem (2978)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/21/2021
Event Type  malfunction  
Manufacturer Narrative
(b)(6). Device evaluated by mfr. : returned product consisted of a quantum maverick balloon catheter. The device was microscopically and visually examined. At 50. 2cm from strain relief there was a kink in the hypotube and full separation of device at 53. 5cm from strain relief. There was blood in the guidewire lumen. There was contrast and blood in the folds of the balloon and the balloon was tightly folded. The device also had tip damage. Product analysis does not confirm reported allegation of balloon damage to the device as there was no damage found to the balloon. There was unreported damage to the device as there was a separation of the hypotube, a hypotube kink and tip damage.
 
Event Description
Reportable based on device analysis completed on 07may2021. It was reported that the balloon was damaged. A 4. 0mm x 12mm quantum maverick was seleced for use. However, it was noted that the balloon was found damage when unpacked. The procedure was completed with another of the same device. There were no patient complications reported. However, returned device analysis revealed shaft detached/separated.
 
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Brand NameQUANTUM MAVERICK
Type of DeviceCATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key11849643
MDR Text Key251467987
Report Number2134265-2021-06484
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
Report Date 05/19/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/19/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number7010
Device Catalogue Number7010
Device Lot Number0025152032
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/12/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/07/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/04/2020
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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