MAUDE Adverse Event Report: OSCOR INC. TOURGUIDE¿ STEERABLE SHEATH; INTRODUCER, CATHETER

Model Number	TG0705517
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/13/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Conclusion not yet available, evaluation in process.A follow-up report will be submitted as soon as the investigation is complete.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.
Event or Problem Description
It was reported that our usual practice is to use the tourguide steerable sheath to cannulated the visceral arteries of the fenestrated aortic stent graft and deliver a visceral stent graft.On this occasion we noticed that the introducer/dilator did not securely click into the hemostatic valve of the sheath.Usually, our expectation is there is a secure attachment of the introducer/dilator to the sheath.We noticed this and manually held the introducer and sheath together.The tourguide then functioned as expected and right renal artery was cannulated.Due to vessel tortuosity it was necessary to use a second tourguide for the sma.The exact same finding of the introducer/dilator did not attach.Again we continued to use the sheath without issue.Tourguide introducer did not "click in" to the hub of the hemostatic valve during a fenestrated evar procedure.I would just like to highlight this issue as we think it is a change from our usual expectation of this sheath.I have looked at a demo sheath i have for teaching the introducer/dilator on that one does click in securely to the hemostatic valve as expected.There was no clinical issue as we spotted this and the case went well and the patient is recovering well.There is a potential that if this was not noticed the sheath could be advanced without the introducer with potential for vessel injury.
Additional Manufacturer Narrative
The following sections were updated in follow-up 1.Two 7f tourguide steerable introducer sheaths were received back from the customer with the dilators.There were no other accessories.Blood was found on and inside both sheaths and dilators.Note: it could not be determined what sheath belonged to which lot.They were received in separate bags, but the bags were not labeled.They will be labeled as sheath #1 and sheath #2 by the investigator here at oscor.According to the event description summary, there was not a secure attachment of the introducer / dilator to both sheaths.The dilator did not click into the sheath's hub.Sheath / dilator #1: upon evaluation of sheath/dilator 1, it was found that the hub rim of the sheath where the dilator locks into looked normal.The hub of the dilator looked slightly damaged.The dilator passed fully and smoothly through the sheath and the hub of the dilator snapped onto the sheath hub without any issues, snapped securely onto the hub and did not move when lightly pulled.Sheath / dilator #2: upon evaluation of sheath/dilator 2, it was found that the hub rim of the sheath where the dilator locks into looked normal.The hub of the dilator looked damaged.The dilator passed fully and smoothly through the sheath.However, the dilator did not snap easily onto the hub of the sheath.It took more force to snap the dilator hub onto sheath 2 than it did sheath 1, but it snapped securely onto the hub and it did not move when lightly pulled.Returned device analysis revealed both dilators passed fully and smoothly through the sheath.Sheath/dilator 1: the hub of the dilator snapped onto the sheath hub without any issues.Sheath/dilator 2: the dilator did not snap easily onto the hub of the sheath.It took more force to snap the dilator hub onto sheath.It is unknown given the lack of information from the event description how the dilator hubs were damaged causing the end user the inability of snapping the parts together.The dilators are visually inspected during the overmolding process 100% by manufacturing and an additional aql inspection is performed by quality assurance before shipping to the customer.No manufacturing rejects or anomalies of this type were recorded in the device history record.The sheath and dilator passed all inprocess and qa final inspection steps before shipping to the customer, including visual, dimensional and mechanical tests.No manufacturing defects were found.The device history records were reviewed to confirm that the device passed all applicable inprocess and final inspections.Per procedure for (thermoplastic overmolding of parts) sample size: 100% while parts are in process: perform a visual inspection to verify the parts meet applicable cosmetic criteria (e.G.Flash, short shots, gate blush, fm, etc).Per qa procedure (destino dilator in-process and final inspection) sample size: 5 first and 5 last good shots inspect 100% visual inspection: hub to be round and smooth, no irregularities inside.At 12-18" distance, hub shape should be as per drawing, flash <0.75 mm or pinch should not exceed 0.2 mm (use profile projector if needed).Measure id of dilator hub by inserting appropriate pin gauge through hub.Per ifu place dilator inside the sheath and snap on both hubs together.Thread the dilator/sheath assembly over the guidewire, using a slight twisting motion.Note: any device/component inserted through the hemostatic valve of the sheath should be wet and placed through the center of the valve to prevent tearing of the seal and leakage.Based on the investigation, a capa is not required as findings did not identify a design, labeling or manufacturing non-conformity.In addition, there was no new failure mode identified and the risk remains acceptable.The event will be re-evaluated if additional information becomes available.Oscor will continue to monitor this event type and risk.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: TOURGUIDE¿ STEERABLE SHEATH
• Common Device Name: 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: daniel naut ; 3816 desoto blvd.; palm harbor, FL 34683-1816 ; 7279372511
• MDR Report Key: 15229124
• Report Number: 1035166-2022-00097
• Device Sequence Number: 5851300
• Product Code: DYB
• UDI-Device Identifier: 00850232006086
• UDI-Public: 00850232006086
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K120459
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/01/2024
• Device Model Number: TG0705517
• Device Catalogue Number: TG0705517
• Device Lot Number: DP-14190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/03/2022
• Supplement Date Received by Manufacturer: 01/03/2023
• Initial Report FDA Received Date: 08/15/2022
• Supplement Report FDA Received Date: 01/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/12/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 86 YR
• Patient Sex: Male
• Patient Weight: 84 KG