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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC - MAPLE GROVE NC EMERGE® CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS Back to Search Results
Model Number H7493926715300
Device Problems Detachment Of Device Component (1104); Material Rupture (1546)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 02/01/2018
Event Type  Injury  
Manufacturer Narrative
(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 balloon rupture and tip detachment occurred. The chronic totally occluded (cto) target lesion was located in the calcified proximal left anterior descending (lad) artery. A 3. 00 mm x 15 mm nc emerge® balloon catheter was advanced for dilation. After the balloon was inflated to 30 atmospheres, the balloon ruptured and separated into two pieces. The distal tip of the balloon was left in the proximal lad and no attempt was made to retrieve the detached fragment. The procedure was completed with another nc emerge balloon catheter. No further patient complications were reported and the patient's status was fine. The patient is scheduled for further rotational atherectomy on the cto at a later date.
 
Manufacturer Narrative
Device evaluated by mfr. : returned product consisted of a nc emerge balloon catheter. There was contrast and blood in the lumen. The balloon, shaft and tip were examined. Examination of the balloon revealed a complete circumferential tear with scratches on the balloon material. Microscopic examination presented no irregularities in the balloon material that could have contributed to the damage. The shaft was separated at the bi-component weld. The inner separation was jagged, which indicates that the separation was due to tensile overload. The distal end of the device was not returned for analysis. Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities. No other issues were identified during the product analysis. The investigation conclusion is user / use error as there was an act or omission of an act that resulted in a different medical device response than intended by the manufacturer or expected by the user. The nc emerge dfu includes the following indication for use: "do not exceed the rated balloon burst pressure. ¿ the balloon compliance chart in table 2 within the dfu lists 20 atm as the rated burst pressure for 3. 00mm diameter devices. (b)(4).
 
Event Description
It was reported that balloon rupture and tip detachment occurred. The chronic totally occluded (cto) target lesion was located in the calcified proximal left anterior descending (lad) artery. A 3. 00mm x 15mm nc emerge balloon catheter was advanced for dilation. After the balloon was inflated to 30 atmospheres, the balloon ruptured and separated into two pieces. The distal tip of the balloon was left in the proximal lad and no attempt was made to retrieve the detached fragment. The procedure was completed with another nc emerge balloon catheter. No further patient complications were reported and the patient's status was fine. The patient is scheduled for further rotational atherectomy on the cto at a later date.
 
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Brand NameNC EMERGE®
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 Key7297231
MDR Text Key100973011
Report Number2134265-2018-01275
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K141236
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 02/01/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/26/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/10/2020
Device Model NumberH7493926715300
Device Catalogue Number39267-1530
Device Lot Number0021589536
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/06/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/22/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/10/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 02/26/2018 Patient Sequence Number: 1
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