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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 H74939147208010
Device Problems Shaft; Break; Difficult to Remove ; Catheter
Event Type  Injury  
Manufacturer Narrative

(b)(4).

 
Event Description

It was reported that shaft break occurred and catheter withdrawal difficulties were encountered. The target lesion was located in an artery in the leg at the level of the ankle. A 20/300 v-18 control wire was advanced to cross the lesion with very strong angulation at the level of the tibioperoneal trunk with the wire forming almost an elbow, a plication. A 2. 0mmx80mmx150cm sterling balloon catheter was advanced for dilation. However, when the physician removed the balloon, the balloon shaft tore into pieces because of this plication which did not allow it to slide normally on the guidewire. A piece of the balloon remained in the artery and a small open surgery was performed to remove that piece of the balloon that remained in the artery. No further patient complications were reported and the patient's status was good.

 
Manufacturer Narrative

Device avail. For eval. Corrected from yes to no. Device returned to mfr. Corrected from yes to no. Method codes, result codes and conclusion codes updated. Device evaluated by mfr. : the device was not returned for evaluation. 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 and catheter withdrawal difficulties were encountered. The target lesion was located in an artery in the leg at the level of the ankle. A 20/300 v-18 control wire was advanced to cross the lesion with very strong angulation at the level of the tibioperoneal trunk with the wire forming almost an elbow, a plication. A 2. 0mmx80mmx150cm sterling balloon catheter was advanced for dilation. However, when the physician removed the balloon, the balloon shaft tore into pieces because of this plication which did not allow it to slide normally on the guidewire. A piece of the balloon remained in the artery and a small open surgery was performed to remove that piece of the balloon that remained in the artery. No further patient complications were reported and the patient's status was good.

 
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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 Key5508429
Report Number2134265-2016-01846
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,DISTRI
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/18/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/17/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date10/31/2017
Device MODEL NumberH74939147208010
Device Catalogue Number39147-20801
Device LOT Number18559509
Was Device Available For Evaluation? No
Date Returned to Manufacturer03/02/2016
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/24/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/06/2015
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: 03/17/2016 Patient Sequence Number: 1
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