MAUDE Adverse Event Report: OSCOR INC. ADELANTE PEEL-AWAY INTRODUCER SET; INTRODUCER, CATHETER

Model Number	AP07016B5
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/11/2019
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.
Event or Problem Description
The customer reported the length of the dilator was found unusually short, it was found before the device was used.
Additional Manufacturer Narrative
The device was used in treatment.One 7f adelante peel-away introducer sheath was returned with the dilator.There were no other accessories.No visible blood was found on the sheath or dilator.Upon evaluation of the returned product, it was found that the dilator was too short.The length of the dilator per drawing should be 208mm ± 2mm.The returned dilator measured 190mm.Per required drawing, the exposed length of the dilator should be 27mm ± 4mm.The exposed length of the returned dilator was short and only measured 7mm.The sheath was within manufacturing specification per required, at 160mm, specification is 160mm ± 2mm.The probable cause of this failure is operator error.This issue is identified to be isolated and is the first occurrence known from the past 2 years, from the date of awareness.The device history records were reviewed to confirm that the device passed all applicable in-process and final inspections.Per procedure adelante introducer set in-process and final inspection 11.1 first 5 properly tipped parts, inspect 100%.11.1.2 measure dimensions: measure usable dilator length after tipping; from end of hub to tip of tube, using metric ruler.Length should be on specification according to the appropriated drawing.14.2 measure dimensions: sampling plan ansi z 1.4, general level i, normal, aql 0.25 verify the exposed length of standard dilator extending beyond the sheath tip, using metric ruler to be in range of 23mm - 31 mm.The instructions for use (ifu) adelante informs the user: aspiration and saline flushing of the sheath and dilator should be performed to help minimize the potential for air embolism and clot formation.Indwelling introducer sheaths should be internally supported by a catheter, lead, or dilator.Personal awareness training has been conducted to prevent the recurrence of this issue.Based on the investigation, a capa is not required.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: ADELANTE PEEL-AWAY INTRODUCER SET
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): OSCOR INC.; 3816 desoto blvd.; palm harbor FL 34683
• MDR Report Key: 9581946
• Report Number: 1035166-2020-00003
• Device Sequence Number: 14263889
• Product Code: DYB
• UDI-Device Identifier: 10885672100022
• UDI-Public: 10885672100022
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K073100
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2020

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: 12/01/2022
• Device Model Number: AP07016B5
• Device Catalogue Number: AP07016B5
• Device Lot Number: DP-09655
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2019
• Initial Date Received by Manufacturer: 12/16/2019
• Supplement Date Received by Manufacturer: 01/27/2020
• Initial Report FDA Received Date: 01/13/2020
• Supplement Report FDA Received Date: 02/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1