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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OSCOR INC. DESTINO TWIST STEERABLE GUIDING SHEATH INTRODUCER, CATHETER

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OSCOR INC. DESTINO TWIST STEERABLE GUIDING SHEATH INTRODUCER, CATHETER Back to Search Results
Model Number DST0655509
Device Problems Failure to Advance (2524); Device-Device Incompatibility (2919)
Patient Problem Stenosis (2263)
Event Date 04/18/2019
Event Type  malfunction  
Event Description
Product malfunction. The dialator is inconsistent with the sheath size. The obturator was not flexible enough to go through the uni-directional curve of the sheath. Brief history & indications: advanced atherosclerosis who underwent prior left renal stenting with a balloon expandable covered stent. He has right renal atrophy and was noted to have high-grade stenosis of his left renal artery just distal to the stent likely secondary to intimal hyperplasia. He was therefore offered balloon angioplasty and stent extension. Procedural note: no mention of event in procedural note but procedural methodology utilized described as follows: ultrasound-guided access of the right common femoral artery was performed using a 21-gauge micropuncture set. Due to scar tissue this was dilated up to a 9 french dilator over a stiff amplatz wire. A 6. 5 french oscor twist conformable sheath was then advanced up to the level of the left renal artery stent. Under fluoroscopic guidance the conformable sheath was used to selectively catheterize the proximal aspect of the stent and a glidewire and quick cross catheter were able to be easily advanced to the renal hilum. The glidewire was then exchanged for a rosen wire. Left renal arteriogram confirmed high-grade stenosis just distal to the previously placed stent. Next, under fluoroscopic guidance a 5 x 20 mm ever flex protégé stent was successfully deployed in an overlapping fashion with the balloon expandable stent. Drug-eluting balloon angioplasty was then performed with a loop tonics 5 x 4 drug-eluting balloon with prolonged inflation for 1 minute. Completion arteriogram revealed complete resolution of the previous stenosis with widely patent dual branches just distal to the self-expanding uncovered stent. Next, the rosen wire was captured with a quick cross catheter and the oscor sheath was pulled down into the right external iliac artery. An ipsilateral oblique arteriogram was obtained which revealed adequate caliber and location of the access for placement of a closure device. A 6 french angio-seal vip closure device was successfully deployed and excellent hemostasis was obtained.
 
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Brand NameDESTINO TWIST STEERABLE GUIDING SHEATH
Type of DeviceINTRODUCER, CATHETER
Manufacturer (Section D)
OSCOR INC.
3816 desoto blvd
palm harbor FL 34683
MDR Report Key8599167
MDR Text Key144692525
Report Number8599167
Device Sequence Number1
Product Code DYB
UDI-Device Identifier00885672004019
UDI-Public(01)00885672004019(17)220101(10)C816484
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 04/24/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/10/2019
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberDST0655509
Device Catalogue NumberDST0655509
Device Lot NumberC816484
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/24/2019
Event Location Hospital
Date Report to Manufacturer05/10/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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