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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC - MAPLE GROVE EMERGE¿ CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS Back to Search Results
Model Number H7493919315200
Device Problem Kinked (1339)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/07/2017
Event Type  malfunction  
Manufacturer Narrative
Age at time of event: 18 years or older. (b)(4). Device evaluated by mfr. : returned product consisted of an emerge balloon catheter. The balloon was loosely folded with blood in the inflation lumen and balloon. The outer shaft, inner shaft, balloon and tip were microscopically examined. Microscopic examination revealed that the balloon has a pinhole at the marker band. The tip is damaged. There are numerous hypotube and shaft kinks. Inspection of the remainder of the device presented no other damage or irregularities. There was no evidence of any material or manufacturing deficiencies contributing to the damage and the reported difficulty. The investigation conclusion is operational context as the product meets the design and manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited. (b)(4).
 
Event Description
Reportable based on device analysis completed on (b)(6) 2018. It was reported that shaft kinked occurred. The 90% stenosed target lesion was located in the severely tortuous and severely calcified right coronary artery. A 2. 00mm x 15mm emerge balloon catheter was advanced for dilation; however, the shaft got kinked during advancing. The procedure was completed with another of the same device. No patient complications nor injuries were reported. However, returned device analysis revealed balloon pinhole.
 
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Brand NameEMERGE¿
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 Key7240625
MDR Text Key99008458
Report Number2134265-2018-00377
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
PMA/PMN Number
K113220
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation
Type of Report Initial
Report Date 01/10/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/05/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/18/2020
Device Model NumberH7493919315200
Device Catalogue Number39193-1520
Device Lot Number21160782
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/20/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/10/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/25/2017
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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