MAUDE Adverse Event Report: OSCOR INC. ARRIVE¿ BRAIDED TRANSSEPTAL SHEATH; INTRODUCER, CATHETER

Model Number 990061-090

Device Problem Device Damaged by Another Device (2915)

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

Event Date 09/06/2022

Event Type  malfunction  

Event Description

It was reported that the sheath was in the body and going to put the trans-septal needle in, and that's when the side arm of the achieve detached.The sheath was replaced which resolved the issue.It was also reported that an unknown error message was received indicating an "open circuit" error.The catheter was replaced which resolved the issue.The outcome of this case is unknown.No patient complications have been reported as a result of this event.Clarification of event details received 11/10/2022: the arrive sheath was in the patient, and the physician was about to put the transseptal needle into the sheath when the side arm/port detached from the sheath.The sheath was then replaced and no further complications were noted during the case.

Manufacturer Narrative

One 10f arrive braided transseptal sheath was returned from the customer with the dilator.The sideport tubing/stopcock assembly was detached from the hub.There were no other accessories.No visible blood was found on or inside the sheath or dilator.According to the event description summary, the physician was about to put the transseptal needle into the sheath when the side arm/port detached from the sheath.Upon evaluation under a microscope, it was found that there was evidence of adhesive residue on the sideport tubing and on the hub stem.The device history records were reviewed to confirm that the device passed all applicable in-process and final inspections.Returned device analysis confirmed detachment of the sideport tubing.This can happen if the curing time of 4 hours is not fully reached and/or the units are handled or moved around during that time.The manufacturing procedure establishes that the units must remain still until curing time is fully reached.This means that the procedure may not have been followed as established.Retraining was conducted with manufacturing personnel on the applicable procedure to prevent recurrence of this issue.This issue was found to be an isolated event.Oscor will continue to monitor this event type and risk.Note: the tug test data was reviewed and all of the units in this lot passed.Per manufacturing procedure (non-peelable sheath sideport assembly) apply one drop of the adhesive on the pellethane side tube at a distance of 2- 3mm from the end.Spread the adhesive around the od of the tube by rotating the tube 360° while applying the drop of adhesive.Repeat the step by placing a drop of glue approximately 6-7mm from the same end, and spread the glue by rotating the tube while applying the adhesive around the od of the tube.Rotate the tube to ensure that the adhesive is applied all around the circumference of the tube uniformly.Fully insert the tube into the sheath hub sideport opening while rotating it 360°.Wipe away any excess adhesive sticking out of the sideport with a polywipe.After curing (undisturbed, for a minimum of 4 hours) test the joint of each part with a small tug, holding the tube in one hand and the stopcock in the other hand.Discard all parts that detach during the tug, do not attempt to cure parts again.Per qa procedure (introducer sheath, adelante breezeway, in-process and final inspection) sampling plan ansi z 1.4, gen level i, normal, aql 0.40 with the naked eye, inspect sideport tube assembly for excessive glue at both joints: sheath hub to sideport tube stopcock to sideport tube verify sideport tube is securely attached by gently pulling on both joints: sheath hub to sideport tube stopcock to sideport tube per ifu sideport aspiration - aspirate the sideport when withdrawing the catheter, probe, or dilator to remove fibrin deposits that may have accumulated in or on the tip of the sheath.Sideport infusion - infusion through the sideport and catheter should be done after all air is removed from the system.No further follow-up is required.Personnel notification / training was conducted to prevent the recurrence of this issue.Risk is acceptable and oscor will continue to monitor this event type.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: ARRIVE¿ BRAIDED TRANSSEPTAL SHEATH
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): OSCOR INC.; 3816 desoto blvd.; palm harbor FL 34683
• Manufacturer (Section G): OSCOR INC.; 3816 desoto blvd.; palm harbor FL 34683
• Manufacturer Contact: daniel naut ; 3816 desoto blvd.; palm harbor, FL 34683 ; 7279372511
• MDR Report Key: 16342356
• MDR Text Key: 309428906
• Report Number: 1035166-2023-00019
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101497
• 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
• Report Date: 02/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2023
• Device Model Number: 990061-090
• Device Catalogue Number: 990061-090
• Device Lot Number: C1-19239
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2022
• Date Manufacturer Received: 01/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/17/2020
• 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