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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY OFFROAD¿ CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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BOSTON SCIENTIFIC - GALWAY OFFROAD¿ CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number H74939202100540
Device Problems Failure to Advance; Catheter
Event Date 11/06/2015
Event Type  Malfunction  
Manufacturer Narrative

Age at time of event: mid 70s. Device evaluated by mfr: the device was returned for analysis with a 0. 014inch guidewire which was inserted through the balloon catheter and microcatheter. Device analysis revealed a pinhole rupture in the shaft and a punctured hole in the wall of the shaft at 45. 5cm distal to the strain relief. An attempt to remove the microcatheter from the balloon catheter failed. A build-up of solidified blood was present on the surface of the shaft. An examination of the lumen of the balloon catheter could not identify any anomalies which could potentially have contributed to this incident. The device was soaked in 37 degrees water; however, it could not be withdrawn. As a result, the shaft was dissected and the microcatheter was removed. No issues were noted with the tip profile of the microcatheter. No other issues or defects were observed during product analysis of the returned device. 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

Reportable based on device analysis completed on 28apr2016. It was reported that the microcatheter failed to track to re-entry site. The target lesion was located in the left superficial femoral artery (sfa). An offroad¿ re-entry microcatheter was selected for use. During the procedure, the offroad¿ re-entry microcatheter was delivered to reenter the target lesion though a 0. 035 inch non-bsc guidewire. When the offroad¿ re-entry microcatheter was in placed, the physician pulled the 0. 035 inch non-bsc guidewire out and tried to advance a. 014 inch non-bsc guidewire with a trochar. However, the trochar could not passed halfway up to the left common iliac. Several attempts were made but failed. The physician opted to pull everything out from the patient and aborted the procedure. No patient complications were reported and the patient's status is fine. However, device analysis revealed a pinhole rupture in the shaft and a punctured hole in the wall of the shaft at 45. 5cm distal to the strain relief.

 
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Brand NameOFFROAD¿
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
BOSTON SCIENTIFIC - GALWAY
Manufacturer (Section G)
BOSTON SCIENTIFIC - GALWAY
Manufacturer Contact
linda leimer
one scimed place
maple grove , MN 55311
7634941700
MDR Report Key5675041
Report Number2134265-2016-04260
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 04/28/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/24/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date06/12/2017
Device MODEL NumberH74939202100540
Device Catalogue Number392021-0054
Device LOT Number17046456
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer11/23/2015
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/28/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured06/13/2014
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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