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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC CORPORATION AGENT CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS Back to Search Results
Model Number 3825
Device Problem Leak/Splash (1354)
Patient Problem Insufficient Information (4580)
Event Date 01/07/2021
Event Type  malfunction  
Manufacturer Narrative
Device evaluated by mfr: the returned product consisted of an agent (dcb) balloon catheter. The device was microscopically and visually examined. At 19. 8cm from the strain relief the hypotube was kinked. There was contrast in the inflation lumen, and balloon. There was blood present in the guidewire lumen. The balloon was tightly folded and in the folds contrast and blood were both present. At 5cm from the tip of the device the guidewire lumen was bucked for 2mm and a hole was present within the buckle. The product mandrel was observed to be in the device at the damage sight upon return of the device. Inspection of the remainder of the device presented no other damage or irregularities. Product analysis could not confirm the reported event as the balloon was not leaking.
 
Event Description
It was reported that a balloon leak occurred. During preparation and while outside the patient, a 2. 50mm x 15. 00mm agent drug coated balloon (dcb) had a balloon leak. The balloon was inflated once, but it was noticed that the balloon was leaking on inflation. No issues were present upon opening the device from its packaging. The procedure was completed successfully with another balloon. No patient complications resulted in relation to this event. However, the device returned and analysis revealed a hole in the guidewire lumen.
 
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Brand NameAGENT
Type of DeviceCATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer (Section G)
HEMOTEQ AG
adenauerstrasse 15
wuerselen 52146
GM 52146
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key11995741
MDR Text Key256179871
Report Number2134265-2021-07602
Device Sequence Number1
Product Code LOX
Combination Product (y/n)Y
Reporter Country CodeAS
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 06/14/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/14/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number3825
Device Catalogue Number3825
Device Lot Number04470H20
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/11/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/27/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/23/2020
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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