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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC - MAPLE GROVE NC QUANTUM APEX¿ CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS Back to Search Results
Model Number H74939282302010
Device Problem Material Rupture (1546)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/05/2016
Event Type  malfunction  
Manufacturer Narrative
Age at the time of event: 18 years or older. (b)(4). Device evaluated by mfr: the device has not been received for analysis. Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed. (b)(4).
 
Event Description
It was reported that balloon rupture occurred. The 90% stenosed target lesion was located in the severely calcified superficial femoral artery. A 3. 0mmx20mmx143cm nc quantum apex¿ balloon catheter was used to dilate the lesion. The balloon was initially inflated at 8 atmospheres. Upon the second inflation at 5 atmospheres for 5 seconds, the balloon ruptured. The procedure was completed with a different device. No patient complications were reported.
 
Manufacturer Narrative
Device evaluated by mfr. : returned product consisted of a coyote nc balloon catheter and a stopcock. The balloon was loosely folded with blood in the balloon and inflation lumen. Microscopic inspection and functional testing revealed a pinhole in the balloon material, 2mm proximal of the distal markerband. There is no indication the device was inflated over rbp. The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications. The most probable root cause is operational context as device performance was limited due to anatomical procedural factors. (b)(4).
 
Event Description
It was reported that balloon rupture occurred. The 90% stenosed target lesion was located in the severely calcified superficial femoral artery. A 3. 0mmx20mmx143cm nc quantum apex¿ balloon catheter was used to dilate the lesion. The balloon was initially inflated at 8 atmospheres. Upon the second inflation at 5 atmospheres for 5 seconds, the balloon ruptured. The procedure was completed with a different device. No patient complications were reported.
 
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Brand NameNC QUANTUM APEX¿
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 Key6184972
MDR Text Key62692453
Report Number2134265-2016-11915
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
PMA/PMN Number
SIMILAR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/06/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/19/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/28/2018
Device Model NumberH74939282302010
Device Catalogue Number39282-30201
Device Lot Number18883047
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/28/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/23/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/04/2016
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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