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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EMERGE CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

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BOSTON SCIENTIFIC CORPORATION EMERGE CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS Back to Search Results
Model Number 24707
Device Problem Material Puncture/Hole (1504)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/30/2019
Event Type  malfunction  
Manufacturer Narrative
Age at time of event: 18 years or older.
 
Event Description
It was reported that shaft hole/perforation occurred. The 100% stenosed target lesion was located in the moderately tortuous and severely calcified vessel below the knee. A 1. 2mmx15mmx142cm coyote fc balloon catheter was selected for pre-dilatation. However, when the non bsc guidewire was inserted into the distal tip of the balloon, it was noted that it came out 5cm of the balloon. The procedure was completed with a different device. No patient serious injury or adverse event were reported.
 
Manufacturer Narrative
Age at time of event: 18 years or older. Returned product consisted of a coyote fc balloon catheter. The balloon was tightly folded. The tip, balloon, shaft and hypotube were microscopically and visually inspected. Inspection revealed numerous kinks in the hypotube, (inner) shaft damage (buckling) located 61-68mm from the tip with a perforation at 69mm. Inspection of the remainder of the device found no damage or defects. A lab supplied guide wire was used to functionally test the complaint device, as the wire used in the procedure was not returned for analysis. The guide wire was loaded into the tip of the coyote fc and the wire advanced through the inner shaft. When the wire reached the area of the inner shaft bunching, resistance was felt, then the wire exited out of the shaft, and through a perforation/hole in the outer shaft. The reported shaft perforation was confirmed.
 
Event Description
It was reported that shaft hole/perforation occurred. The 100% stenosed target lesion was located in the moderately tortuous and severely calcified vessel below the knee. A 1. 2mmx15mmx142cm coyote fc balloon catheter was selected for pre-dilatation. However, when the non bsc guidewire was inserted into the distal tip of the balloon, it was noted that it came out 5cm of the balloon. The procedure was completed with a different device. No patient serious injury or adverse event were reported.
 
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Brand NameEMERGE
Type of DeviceCATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key8358861
Report Number2134265-2019-01388
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup
Report Date 03/27/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/21/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/11/2020
Device Model Number24707
Device Catalogue Number24707
Device Lot Number22242055
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/11/2019
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/06/2019
Is This a Reprocessed and Reused Single-Use Device? No
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