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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE STERLING¿ SL CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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BOSTON SCIENTIFIC - MAPLE GROVE STERLING¿ SL CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number H74939148308090
Device Problems Shaft; Break
Event Date 09/30/2015
Event Type  Malfunction  
Manufacturer Narrative

(b)(4).

 
Event Description

It was reported that shaft break occurred. A 3. 0mmx80mmx90cm sterling sl balloon catheter was selected for use to dilate the lesion. During preparation, when trying to load the wire into the balloon catheter, the tip of the wire entered into the broken blue inner part of the balloon catheter. It was reported the manipulation of the product was tender and ok, it is believed that the balloon must have been broken before manipulation. The procedure was completed with a different device.

 
Manufacturer Narrative

Device evaluated by mfr: returned device consisted of a sterling balloon catheter with no other devices. The balloon was loosely folded. Microscopic inspection revealed a hole in the inner, 61mm from the tip of the device. The hole showed evidence of being punctured from inside of the lumen and pushed outside of the inner lumen, as made when a guidewire is being loaded from the tip. Microscopic inspection found no irregularities or damage to the tip of the device. The guidewire used in the procedure was not returned with the complaint device. Functional testing was conducted using a kinetix plus guidewire. The kinetix was advanced through the tip of the complaint unit, but stopped advancing when the wire reached the hole in the inner lumen, with the wire tip entering the hole. Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities. 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

It was reported that shaft break occurred. A 3. 0mmx80mmx90cm sterling sl balloon catheter was selected for use to dilate the lesion. During preparation, when trying to load the wire into the balloon catheter, the tip of the wire entered into the broken blue inner part of the balloon catheter. It was reported the manipulation of the product was tender and ok, it is believed that the balloon must have been broken before manipulation. The procedure was completed with a different device.

 
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Brand NameSTERLING¿ SL
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
BOSTON SCIENTIFIC - MAPLE GROVE
one scimed place
maple grove MN 55311
Manufacturer Contact
linda leimer
one scimed place
maple grove , MN 55311
7634941700
MDR Report Key5189261
Report Number2134265-2015-07156
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,DISTRI
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/30/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/29/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date10/31/2016
Device MODEL NumberH74939148308090
Device Catalogue Number39148-30809
Device LOT Number17383071
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/04/2015
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/16/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured10/24/2014
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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