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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 H7493895912200
Device Problems Hole In Material (1293); Device Damaged Prior to Use (2284)
Patient Problem No Patient Involvement (2645)
Event Date 03/27/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that balloon pinhole occurred. A 2. 00 mm x 12 mm apex¿ balloon catheter was selected for use to dilate a lesion. However, when the balloon was flushed and prepped, it was felt that the balloon material was compromised and a pinhole was noted. The device was not used inside the patient and the procedure was completed with a different device. No patient complications were reported.
 
Manufacturer Narrative
Returned product consisted of a apex balloon catheter. The balloon was loosely folded with contrast in the balloon and lumen. There were numerous hypotube kinks. There was tip damage. Functional testing with an inflation filled with water was used to inflate the balloon to the rated burst pressure and revealed no damages. Inspection of the proximal and distal markerband did not reveal any damages. The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications. The root cause is not confirmed as there was no evidence of the alleged issue or any anomalies which could have contributed to the reported difficulty. (b)(4).
 
Event Description
It was reported that balloon pinhole occurred. A 2. 00mm x 12mm apex balloon catheter was selected for use to dilate a lesion. However, when the balloon was flushed and prepped, it was felt that the balloon material was compromised and a pinhole was noted. The device was not used inside the patient and the procedure was completed with a different device. No patient complications were reported.
 
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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 Key6511278
MDR Text Key73390383
Report Number2134265-2017-03854
Device Sequence Number1
Product Code LOX
UDI-Device Identifier08714729475477
UDI-Public(01)08714729475477(17)20200131(10)20203773
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 04/01/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/21/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/31/2020
Device Model NumberH7493895912200
Device Catalogue Number38959-1220
Device Lot Number20203773
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/19/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/27/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/25/2017
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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