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

Model Number	TG0655509
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One 6.5f tourguide steerable introducer sheath was received back from the customer with the dilator.There were no other accessories.No visible blood was found on or inside the sheath or dilator.According to the event description summary, the dilator does not click shut into the tourguide.Upon evaluation, it was found that the hub cap rim of the sheath where the dilator locks into looked normal with no obvious signs of damage in comparison to the drawing.The geometry of the hub on the dilator looked abnormal in the area that locks into the sheath's hub cap in comparison to the drawing.The dilator hub was no longer uniform in diameter and looked like the user was trying to force the dilator to lock onto the sheath causing the hub material to crush and buckle upward.The dilator passed fully and smoothly through the sheath.However, the dilator would not lock/click onto the hub of the sheath.The device history records were reviewed to confirm that the device passed all applicable in-process and final inspections.Returned device analysis revealed that the dilator would not lock onto the sheath.The reason for return was confirmed.A direct assessment of on hand inventory revealed that the true physical dimension present in the molded dilators is 0.147", which requires excessive force to mate with the 0.137" snap cap inner diameter (id).Further investigation on the drawings corresponding to mold 5007, indicated that the intended outside diameter for the dilator snap feature is indeed 0.147" after the shrinkage factor is considered.The mold drawing indicated that the dimension was inadvertently updated to 0.147" from 0.142", which would be indicative of the point where the reported condition was introduced.So, the most probable root cause is shut-off dimensionally out of spec.Manufacturing and qa personnel have been notified of this issue.Capa was opened to investigate the root cause and implement corrective action to prevent recurrence of this issue.Per (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 procedure: 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.This report was inadvertently missed; therefore, the submission is late.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
The customer reported the dilator does not "click' shut into the tourguide.Thus, it does not stay in place while advancing into the patient.The event occurred during the procedure and the patient received treatment.The customer stated the issue has not resolved.The healthcare professional stated the cause of the event was error of guide.

• 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: 17699702
• Report Number: 1035166-2023-00095
• Device Sequence Number: 15139936
• Product Code: DYB
• UDI-Device Identifier: 00850232006031
• UDI-Public: 00850232006031
• 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
• Report Date (Section B): 09/07/2023

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: 02/01/2025
• Device Model Number: TG0655509
• Device Catalogue Number: TG0655509
• Device Lot Number: DP-15127
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/30/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/18/2022
• Initial Report FDA Received Date: 09/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/21/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown