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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 H74939147308010
Device Problems Balloon; Torn Material
Event Date 12/10/2015
Event Type  Malfunction  
Manufacturer Narrative

(b)(4).

 
Event Description

It was reported that the balloon was separated from the catheter. The target lesion was an aneurysm located in a common femoral artery (cfa). A 6fr non bsc guide sheath was placed and a 3. 0mmx80mmx150cm sterling sl balloon catheter was selected for an open repair of the cfa aneurysm and post thrombectomy of the tibioperoneal (tp) trunk. The balloon was inserted into sheath without any difficulty. An attempt was then made to inflate the balloon however it was noted that the balloon appeared to be separated from the catheter. The device was completely removed from the patient's body and the procedure was completed with another balloon catheter. No patient complications were reported.

 
Manufacturer Narrative

Device evaluated by mfr: returned product consisted of a sterling balloon catheter. There was contrast on the device. The balloon was loosely folded. Functional testing was performed by attaching an inflation device filled with water to the device. When positive pressure was applied, a stream of water emitted from the balloon wall. The balloon was microscopically examined and there was a pinhole in the balloon wall 7. 5cm from the tip of the device from the tip of the device. Microscopic examination presented no irregularities in the balloon material or the ro marker that could have contributed to the damage. Microscopic inspection found no irregularities or defects to the proximal bond. Microscopic and tactile inspection found no irregularities or defects. Inspection of the remainder of the device revealed no 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 the balloon was separated from the catheter. The target lesion was an aneurysm located in a common femoral artery (cfa). A 6fr non bsc guide sheath was placed and a 3. 0mmx80mmx150cm sterling sl balloon catheter was selected for an open repair of the cfa aneurysm and post thrombectomy of the tibioperoneal (tp) trunk. The balloon was inserted into sheath without any difficulty. An attempt was then made to inflate the balloon however it was noted that the balloon appeared to be separated from the catheter. The device was completely removed from the patient's body and the procedure was completed with another balloon catheter. No patient complications were reported.

 
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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 Key5344529
Report Number2134265-2015-09142
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/10/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/05/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date08/17/2016
Device MODEL NumberH74939147308010
Device Catalogue Number39147-30801
Device LOT Number17207806
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer12/22/2015
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/13/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/21/2014
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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