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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC - MAPLE GROVE APEX¿ CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS Back to Search Results
Model Number H7493895940200
Device Problem Material Rupture (1546)
Patient Problem Perforation of Vessels (2135)
Event Date 11/25/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that balloon rupture and vessel perforation occurred. The target lesion was located in the posterior descending artery (pda). A 2. 00mm x 40mm apex¿ balloon catheter was advanced for dilatation. However, during the first inflation at 12 atmospheres, the balloon ruptured. A perforation on the artery was then noted and a stent was deployed to cover the perforation. No patient complications were reported and the patient's status was fine.
 
Manufacturer Narrative
Device evaluated by mfr: returned device consisted of a apex balloon catheter. The balloon was loosely folded, with blood and in the wire lumen, hub and balloon. The tip, balloon, hypotube and distal shaft were microscopically and tactile inspected. Inspection revealed a small pinhole in the balloon material at the distal edge of the distal markerband with numerous kinks in the hypotube. Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities. 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 and vessel perforation occurred. The target lesion was located in the posterior descending artery (pda). A 2. 00mm x 40mm apex¿ balloon catheter was advanced for dilatation. However, during the first inflation at 12 atmospheres, the balloon ruptured. A perforation on the artery was then noted and a stent was deployed to cover the perforation. No patient complications were reported and the patient's status was fine.
 
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Brand NameAPEX¿
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 Key6185163
MDR Text Key62706114
Report Number2134265-2016-11804
Device Sequence Number1
Product Code LOX
UDI-Device Identifier08714729475910
UDI-Public(01)08714729475910(17)20190930(10)19776998
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,Followup
Report Date 12/02/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/19/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/30/2019
Device Model NumberH7493895940200
Device Catalogue Number38959-4020
Device Lot Number19776998
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/07/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/04/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/29/2016
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: 12/19/2016 Patient Sequence Number: 1
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