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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE STERLING¿ CATHETER, PERCUTANEOUS

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BOSTON SCIENTIFIC - MAPLE GROVE STERLING¿ CATHETER, PERCUTANEOUS Back to Search Results
Model Number H74939032302290
Device Problems Shaft; Break
Event Date 06/12/2018
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 shaft break occurred and patient had significant bleeding. The target lesion was located in the occluded and moderately calcified anterior tibial artery. A 3. 0x220x90 (4f) sterling¿ balloon catheter was advanced for dilatation and it was noted that the shaft was broken. The broken piece was recovered; however, the patient experienced significant bleeding. All the hardware was removed and compression was performed to stop the bleeding. It was noted that the guide wire was too thin and it was not possible to return the introducer sheath which caused the bleeding and the procedure was stopped. No further patient complications were reported.

 
Manufacturer Narrative

Device evaluated by mfr. : returned product consisted of a sterling balloon catheter without the distal inner and the distal portion of the balloon. There is blood in the inflation lumen and balloon. The outer shaft, inner shaft, balloon and tip were microscopically examined. The balloon is completely circumferential torn off 11 mm from the proximal balloon cone. The distal balloon and tip were not returned. The balloon also has an 11 mm longitudinal tear starting at the proximal balloon cone. The inner shaft was completely separated 63. 8 cm from the strain relief. The fractured/separated end of the inner shaft was stretched and jagged which indicates the shaft separation was due to tensile forces. The distal shaft, distal balloon and tip were not returned for analysis. There was no evidence of any material or manufacturing deficiencies contributing to the damage or the reported difficulty. The investigation conclusion is operational context as the product meets the design & manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited. (b)(4).

 
Event Description

It was reported that shaft break occurred and patient had significant bleeding. The target lesion was located in the occluded and moderately calcified anterior tibial artery. A 3. 0x220x90 (4f) sterling¿ balloon catheter was advanced for dilatation and it was noted that the shaft was broken. The broken piece was recovered; however, the patient experienced significant bleeding. All the hardware was removed and compression was performed to stop the bleeding. It was noted that the guide wire was too thin and it was not possible to return the introducer sheath which caused the bleeding and the procedure was stopped. No further patient complications were reported.

 
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Brand NameSTERLING¿
Type of DeviceCATHETER, 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 Key7664586
Report Number2134265-2018-05895
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation PHARMACIST
Type of Report Initial,Followup
Report Date 06/13/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/05/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date09/22/2019
Device MODEL NumberH74939032302290
Device Catalogue Number39032-30229
Device LOT Number21914435
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer07/05/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/03/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/26/2018
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: 07/05/2018 Patient Sequence Number: 1
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