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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 H7493895915300
Device Problems Break (1069); Device Damaged Prior to Use (2284)
Patient Problem No Patient Involvement (2645)
Event Date 04/18/2017
Event Type  malfunction  
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 shaft break occurred. During preparation of a 3. 00mm x 15mm apex¿ balloon catheter, when the stylet was removed from the tip of the balloon, it was noted that the shaft separated at the proximal monorail port. The device was not used inside the patient and the procedure was completed with another 3. 00mm x 15mm apex balloon catheter. No patient complications were reported and the patient¿s status was fine.
 
Manufacturer Narrative
Device evaluated by mfr: returned product consisted of the proximal portion of the apex balloon catheter. The distal shafts after the exit notch, the balloon, markerbands, and tip were not returned for analysis. The hypotube and portion of the shaft that was returned for analysis was microscopically examined. The distal shaft was stretched 2. 5mm ¿ 7. 5mm distal of the exit notch and separated 7. 5mm distal of the exit notch. The separated end of the shaft appeared to be jagged and damaged, which indicates that the separation was due to tensile overload. 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 manufacturing batch record review confirmed that the device met all material, assembly and performance specifications. The most probable root cause is considered handling damage as the event occurred without direct patient contact. (b)(4).
 
Event Description
It was reported that shaft break occurred. During preparation of a 3. 00mm x 15mm apex¿ balloon catheter, when the stylet was removed from the tip of the balloon, it was noted that the shaft separated at the proximal monorail port. The device was not used inside the patient and the procedure was completed with another 3. 00mm x 15mm apex balloon catheter. No patient complications were reported and the patient¿s status was fine.
 
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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 Key6559404
MDR Text Key74901468
Report Number2134265-2017-04488
Device Sequence Number1
Product Code LOX
UDI-Device Identifier08714729475637
UDI-Public(01)08714729475637(17)20200229(10)20293293
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P860019
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 04/20/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/10/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/29/2020
Device Model NumberH7493895915300
Device Catalogue Number38959-1530
Device Lot Number20293293
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/12/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/17/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/16/2017
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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