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

Model Number	DST0655509
Health Effect - Clinical Code	Stenosis (2263)
Date of Event	04/18/2019
Type of Reportable Event	Malfunction
Event or Problem 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.

• Brand Name: DESTINO TWIST STEERABLE GUIDING SHEATH
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): OSCOR INC.; 3816 desoto blvd; palm harbor FL 34683
• MDR Report Key: 8599167
• Report Number: 8599167
• Device Sequence Number: 16689482
• Product Code: DYB
• UDI-Device Identifier: 00885672004019
• UDI-Public: (01)00885672004019(17)220101(10)C816484
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/24/2019
• Report Date (Section F): 04/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: DST0655509
• Device Catalogue Number: DST0655509
• Device Lot Number: C816484
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 05/10/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 104
• Date Report Sent to FDA: 04/24/2019