MAUDE Adverse Event Report: OSCOR INC. DESTINO TWIST STEERABLE GUIDING SHEATH 7F; INTRODUCER, CATHETER

Model Number DST0704509

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Aneurysm (1708); No Information (3190)

Event Date 05/10/2018

Event Type  malfunction  

Manufacturer Narrative

The manufacturer attempted twice to obtain the device for analysis, plus the following information: additional patient information, more device details and additional event information, none of these were achieved.The device was not returned for analysis, therefore, the clinical observation could not be confirmed.A review of the device history record (dhr) was conducted and there were no manufacturing rejects or anomalies recorded in the dhr.The device passed all in-process and qa final inspection steps before shipping to the customer, including visual, dimensional and mechanical testing.A complaint review of the reported lot found no additional reports involving this lot number.Per the destino steerable guiding sheath in-process and final inspection procedure it indicates to: verify the deflection to be maximum 180 degrees in one direction.This test is preformed 100 percent by qa.Per the instructions for use (ifu) it instructs the user to: do not force the steerable sheath assembly if significant resistance is encountered during the insertion or passage.If resistance is encountered, determine the cause and correct before continuing the procedure.Based upon the investigation, the complaint cannot be confirmed.However, this issue has been previously identified and a capa was initiated to address deflection related issues.Analysis shows the risk remains medium for this failure mode.The event will be re-evaluated if additional information becomes available.Oscor will continue to monitor this event type and risk.

Event Description

The customer reported fenestrated endograft.Oscor guiding sheath did not function properly.It did not rotate, the device did not do what it was supposed to do.They reported the original intended procedure was a percutaneous four-vessel fenestrated-evar with pmeg zfen-p-28-124-r including distal bifurcate zfen-d12-28-76-c and stented fenestrations for the celiac, sma, and bilateral renal arteries.Preclose of bilateral femoral access with 20 fr sheath on the right and 14 fr sheath on the left.

Event Description

Additional information was received on 11/05/2018: the reporter was not sure at what point during the procedure the event occurred.The procedural note states: the proximal fenestrated endograft was then successfully deployed.From the contralateral femoral access site, the distal portion of the proximal fenestrated device was selectively catheterized.A lunderquist wire was advanced into the proximal device and a 14 french sheath was advanced over this stiff wire into the proximal device.The valve of the 14 french sheath was then sequentially punctured.The fenestrations and target arteries were then selectively catheterized using a 7.0 french oscor twist conformable sheath, quick cross catheter and a glidewire.Additionally, the sma required the use of a pro-grate microcatheter and a v 18 wire to cross the high-grade stenosis at the origin of the sma.With each individual vessel cannulation, the glidewire was exchanged for a rosen wire.The quick cross catheter and conformable sheath were then sequentially removed.The conformable sheath was left in the last vessel cannulated with the dilator in place.Next, the constraining wire and proximal fixation struts were deployed.The proximal seal zone was then balloon molded using a cook coda balloon.Balloon expandable covered stents were then advanced over the rosen wires in a sequential fashion and deployed with proximal flaring using the flash ostial system balloon within the fenestrated stent graft.No additional medical or surgical procedures were required.A replacement device was used instead of the complaint device.There was no adverse event associated with this complaint.The patient was doing fine after surgery.There was minimal delay during the procedure due to this issue.

Manufacturer Narrative

Corrected data is as follows: correction sections: date of event is (b)(6) 2018, and contact office name - (b)(6).Oscor inc.Is submitting the above report to comply with 21 cfr part 803, the medical device reporting regulation.The report is based upon information obtained by oscor inc.Which the company may not have been able to investigate or verify prior to the date the report was required by fda.This report does not constitute an admission that the device, oscor inc., or its employees, caused or contributed to the event described in this report.Nor does this report reflect a conclusion by fda, oscor inc., or its employees, that the report constitutes an admission that the device, oscor inc., or its employees caused or contributed to the event described in this report.

• Brand Name: DESTINO TWIST STEERABLE GUIDING SHEATH 7F
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): OSCOR INC.; 3816 de soto blvd.; palm harbor FL 34683
• MDR Report Key: 7639175
• MDR Text Key: 112858398
• Report Number: 1035166-2018-00061
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00885672004125
• UDI-Public: 00885672004125
• Combination Product (y/n): N
• PMA/PMN Number: K140406
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 12/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 12/01/2020
• Device Model Number: DST0704509
• Device Catalogue Number: DST0704509
• Device Lot Number: C8-11835
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 14 FR SHEATH; 20 FR SHEATH; DISTAL BIFUCATE ZFEN-D12-28-76-C; PMEG ZFEN-P-28-124-R; STENTED FENESTRATED GRAFT
• Patient Age: 79 YR