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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC CORPORATION NC QUANTUM APEX CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS Back to Search Results
Device Problems Inflation Problem (1310); Material Puncture/Hole (1504)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/14/2021
Event Type  malfunction  
Manufacturer Narrative
Patient identifier: (b)(6).
 
Event Description
(b)(6) registry. It was reported that a balloon perforation occurred. On (b)(6) 2021, the subject presented with unstable angina and the index procedure was performed on the same day. Heparin and other antithrombotic medication were administered at the time of the index procedure. The subject was on a prior regimen of aspirin (greater than or equal to 72 hours), and was on a prior regimen of antiplatelet medication other than aspirin (greater than or equal to 72 hours at the time of index procedure. A loading dose of 81mg of aspirin, and a loading dose of 90mg of ticagrelor was given prior to the procedure. The target lesion was located at the proximal left circumflex (lcx) (cass site #18) and was 15mm long, with a reference vessel diameter of 3. 50mm. The target lesion was predilated with a 3. 0mm x 15mm balloon with 95% residual stenosis. Following predilation, the lesion was successfully treated with a 3. 50mm x 30mm agent drug coated balloon device with 20% residual stenosis and timi flow 3. Post dilation was not performed. On (b)(6) 2021, the subject was discharged. On (b)(6) 2021, on the same day as the index procedure, post discharge, the subject had mid sternal chest pain that woke him up from seep. The pain was associated with nausea and shortness of breath lasting one to two minutes before spontaneously resolving. The subject continued to experience the pain even the next night. On (b)(6) 2021, three days post index procedure, the subject was hospitalized for further evaluation. On the same day, angiography revealed a 95% stenosed lcx. An ecg revealed st and t wave abnormality. These were similar findings as compared to post procedure. The subject was diagnosed with unstable angina. Revascularization was recommended. The 95% stenosed mid cx was treated with a 3mm x 15mm non boston scientific nc plus balloon, shock wave, and a 4mm x 22mm non boston scientific stent. Following this, the lesion was treated with another manufacturers 3mm x 15mm balloon and a 4mm x 15mm nc quantum apex balloon. Subsequently, there was a perforation noted in the nc quantum apex balloon. Hence, a bed side echo was performed with trace effusion via rfa (angio seal). The echo revealed a small amount of echogenic material anterior to the right ventricle, which is similar to previous echo findings on (b)(6) 2016. Post treatment, a course complication by trace ooze was noted. The rationale for intervention was angina and ecg changes. The event was also treated with medication. Post procedural ecg revealed, there was mid left atrial enlargement noted, the aortic valve was mildly calcified, and there was a small amount of echogenic material anterior to the right ventricle with no significant free fluid. On (b)(6) 2021, the event was considered to be recovered and resolved, and the subject was discharged.
 
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Brand NameNC QUANTUM APEX
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
ballybrit business park
galway
EI
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key12783254
MDR Text Key280933238
Report Number2134265-2021-14092
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/06/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/09/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/13/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Initial

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