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

Model Number DCR1207122

Device Problems Difficult to Advance (2920); Air/Gas in Device (4062)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/08/2021

Event Type  malfunction  

Manufacturer Narrative

Conclusion not yet available, evaluation in process.A follow-up report will be submitted as soon as the investigation is complete.

Event Description

It was reported that on (b)(6) 2021 during a cryoablation procedure the doctor performed the transseptal puncture with an abbott sl sheath in combination with a transseptal needle.The abbott sl sheath and the transseptal needle were removed after the transseptal puncture, however, the guidewire was left in place to guide the steerable sheath to the left atrium.The doctor started to prepare the destino reach and flushed the sheath and dilator.The dilator was also moistened for a smooth insertion of the dilator into the sheath.During the insertion of the dilator into the steerable sheath the doctor recognized that it was extremely difficult to insert the dilator into the steerable sheath.It was necessary to push the dilator with pressure into the sheath.After preparing the dilator and the steerable sheath the product was inserted over the guidewire to the left atrium of the patient.After reaching the correct position in the left atrium the doctor removed the dilator from the sheath.During the removal of the dilator the doctor had difficulties and had to use force to pull the dilator out of the sheath.After removing the dilator the doctor recognized a bubble or a foreign material in the hemostatic valve of the steerable sheath, therefore, the doctor decided to change the sheath and use a new steerable sheath.There was approximately a 5 minute delay due to the exchange of the steerable sheath.No patient harm reported.

Manufacturer Narrative

The following sections were updated in follow-up 1.B4, d9, g3, g6, h2, h3, h6, h10 two 12f destino reach sheaths were returned for analysis.Traces of blood were found inside and outside the sheaths.The sheaths were leak tested and no leak was observed.The sheath was manually leak tested with the syringe connected to the stopcock and the tip occluded.The sheath did not exhibit leakage when tested using this method.The sheath was then tested using the iso 11070 for liquid leakage test method.The device was occluded at the distal tip and pressurized to 38kpa and held at this pressure for 30 seconds and no leakage was observed from the hemostatic valve.The sheath was further pressurized beyond 300kpa and no leakage was observed from the stopcock, sideport or through the handle.The hemostatic valves of both sheaths were viewed under a 10x microscope and looked normal with no anomalies.It was observed that the dilator could only be inserted approximately 41cm and 38 cm in through the sheath valve.The measured sheath tip i.D and dilator o.D were found to be within specifications for both sheaths.But the dilator could be inserted into the sheath only half way.The cause of this issue is due to irregularities in the sheath shaft i.D along the length.The device history records were reviewed to confirm that the device passed all applicable in-process and final inspections.The investigation and device evaluation showed that both sheaths passed leak test and there was no foreign material on the hemostatic valve.The dilator was only able to pass through the sheaths only approximately half way which could be due to sheath shaft id irregularities along the length.Capa has been initiated to further investigate this issue.Ifu is provided with the product.Never advance, torque or withdraw sheath when resistance is met.Determine the cause of fluoroscopy and then take remedial action.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.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 REACH STEERABLE GUIDING SHEATH
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): OSCOR INC.; 3816 desoto blvd.; palm harbor FL 34683 1816
• Manufacturer (Section G): OSCOR INC.; 3816 desoto blvd.; palm harbor FL 34683 1816
• Manufacturer Contact: doug myers ; 3816 desoto blvd.; palm harbor, FL 34683-1816 ; 7279372511
• MDR Report Key: 13108691
• MDR Text Key: 282910098
• Report Number: 1035166-2021-00160
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00885672007430
• UDI-Public: 00885672007430
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K151951
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DCR1207122
• Device Catalogue Number: DCR1207122
• Device Lot Number: DP-13937
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2021
• Date Manufacturer Received: 05/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/02/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1