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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE NC QUANTUM APEX BALLOON CATHETER CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

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BOSTON SCIENTIFIC - MAPLE GROVE NC QUANTUM APEX BALLOON CATHETER CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS Back to Search Results
Model Number UNK651
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Intimal Dissection (1333)
Event Date 06/29/2017
Event Type  Injury  
Manufacturer Narrative
Device evaluated by mfr: it is indicated that the device will not be returned for evaluation. A review of the batch history, historical trending, and similar complaint trending review for the product family will be conducted. If there is any further relevant information from that review, a supplemental medwatch will be filed. (b)(4).
 
Event Description
Same case as mdr id: 2134265-2017-07286. It was reported that vessel dissection occurred. The patient was diagnosed with single vessel disease (svd) in left anterior descending artery (lad). Vascular access was obtained via the femoral artery. The 85% stenosed, 14 x 3. 5 mm, eccentric, de novo target lesion was located in the non-calcified lad. After a non bsc guide wire crossed the lesion, a non-compliance balloon catheter was advanced for pre-dilation at 12 atmospheres. Subsequently, a 3. 50 x 16 mm promus element ¿ drug-eluting stent was implanted to the lesion. Post-dilation was then performed with a quantum apex balloon catheter. Following fluoroscopy, a vessel dissection was noted at the distal portion of the stent. A 3. 50 x 16 mm promus element stent was deployed to cover the dissection and the procedure was completed. No further patient complications were reported and the patient¿s status was stable and responding well to medications.
 
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Brand NameNC QUANTUM APEX BALLOON CATHETER
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 Key6744794
MDR Text Key81078722
Report Number2134265-2017-07901
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
K121667
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation
Type of Report Initial
Report Date 07/05/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/26/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberUNK651
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/05/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 07/26/2017 Patient Sequence Number: 1
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