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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 H7493918915200
Device Problem Kinked (1339)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/21/2016
Event Type  malfunction  
Manufacturer Narrative
Age at time of event: 18 years or older.  (b)(4).   device evaluated by mfr: returned product consisted of the emerge balloon catheter in two pieces. There was contrast and blood in the inflation lumen and balloon and blood in the guidewire lumen. The balloon was loosely folded. The hypotube and shaft were microscopically examined. The hypotube was kinked 75. 5cm from the strain relief and there was a complete hypotube separation 70. 5cm from the strain relief. The hypotube fracture surface was ovaled, which suggests the device was kinked prior to separation. Inspection of the remainder of the device revealed no other damage or irregularities. No other issues were identified during the product analysis. Device analysis determined the condition of the returned device was consistent with the reported information. 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
Reportable based on device analysis completed on 19-dec-2016. It was reported that shaft kink occurred. The target lesion was located in the coronary artery. A 2. 00mm x 15mm emerge¿ balloon catheter was advanced to dilate the lesion. However, the balloon shaft was kinked. The procedure was completed with another of the same device. No patient complications were reported and the patient's status was stable. However, returned device analysis revealed hypotube broken.
 
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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 Key6248385
MDR Text Key64732241
Report Number2134265-2016-12370
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeCN
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 12/19/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/12/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/31/2018
Device Model NumberH7493918915200
Device Catalogue Number39189-1520
Device Lot Number19191135
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/01/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/19/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/27/2016
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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