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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 H7493895915200
Device Problem Fracture (1260)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/07/2016
Event Type  malfunction  
Manufacturer Narrative
Age at time of event: 18 years old 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 shaft break occurred. The target lesion was located in a coronary artery. A 2. 00mm x 15mm apex¿ balloon catheter was advanced for dilatation. However, upon introduction, the shaft was fractured. The procedure was completed with another of the same device. No patient complications were reported.
 
Manufacturer Narrative
Device evaluated by mfr. : returned product consisted of a apex balloon catheter. The balloon was tightly folded. There was contrast in the inflation lumen. There was blood in between balloon folds. The outer shaft, inner shaft, balloon and tip were microscopically examined. There were numerous hypotube kinks. There was no evidence of any material or manufacturing deficiencies contributing to the damage. 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 shaft break occurred. The target lesion was located in a coronary artery. A 2. 00mm x 15mm apex¿ balloon catheter was advanced for dilatation. However, upon introduction, the shaft was fractured. The procedure was completed with another of the same 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 Key6190704
MDR Text Key62914097
Report Number2134265-2016-12086
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeCN
PMA/PMN Number
P860019
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/08/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/20/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/30/2019
Device Model NumberH7493895915200
Device Catalogue Number38959-1520
Device Lot Number19121482
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/19/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/06/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/08/2016
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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