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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC - MAPLE GROVE QUANTUM MAVERICK BALLOON CATHETER CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS Back to Search Results
Model Number UNK351
Device Problem Device Slipped (1584)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/15/2014
Event Type  Injury  
Manufacturer Narrative
(b)(4). Device evaluated by mfr. : it is indicated that the device will not be returned for evaluation. If there is any further relevant information obtained, a supplemental medwatch will be filed. (b)(4).
 
Event Description
Same case as mdr id# 2134265-2018-06286 (b)(6) study. It was reported that balloon positioning/placement issue occurred. In (b)(6) 2013, the patient presented due to unstable angina and cardiac catheterization was recommended. The target lesion was a de novo lesion located in the proximal right coronary artery (rca) with 99% stenosis and was 5mm long with a reference vessel diameter of 4mm. Following pre-dilatation with a 3. 00mm balloon, a 3. 0x16mm promus element plus stent was introduced but could not be advanced beyond the ostium of the rca. The same balloon was used again and inflated several times up to 14atm. A 4. 00x16mm promus element¿ plus drug-eluting stent (des) was implanted and following post dilatation, the residual stenosis was 0% with timi 3 flow noted. On the following day, the patient was discharged on aspirin and clopidogrel. In (b)(6) 2014, the patient presented to hospital for a follow up care visit. The patient reported complaints of significant dyspnea on exertion which was worse than last visit, associated with tiredness and shortness of breath. The patient was diagnosed with unstable angina and was hospitalized the same day. Coronary angiography revealed 80% in-stent restenosis located in the proximal rca. During treatment of isr of the study stent, initially a 4. 5 x 15 mm quantum maverick balloon catheter was used which inflated to high pressure. This resulted in watermelon seeding of the balloon. Follow-up angiography demonstrated persistent 40% residual stenosis. A 5mm quantum maverick balloon catheter was inflated to 20 atmospheres with 30% residual stenosis and the procedure was completed with no other complications. The following day, the event was considered as resolved and the patient was discharged from the hospital on the same day.
 
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Brand NameQUANTUM MAVERICK 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 Key7675663
MDR Text Key113618423
Report Number2134265-2018-06373
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P860019
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 06/20/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/10/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberUNK351
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 Received06/20/2018
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: 07/10/2018 Patient Sequence Number: 1
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