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

Model Number	AP07016B5
Medical Device Problem Code	Material Too Rigid or Stiff (1544)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/21/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product was provided for analysis.The procedure was completed successfully and no adverse event with the patient.The customer stated that after the lead reached the right atrium, an attempt was made to peel the sheath away, but the sheath shaft part was torn halfway through the attempt.The device history records were reviewed to confirm that the device passed all applicable in-process and final inspections.No product was returned to oscor inc.For evaluation; however, a complaint notification was provided.Without the return of the actual device in question for evaluation, oscor inc.Is unable to determine the exact cause for this incident.At this time, it is not possible to assign a definitive root cause for the event as reported.The complaint is non-verifiable as the product was not returned for evaluation.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
Summary: difficulty in peeling away the sheath.The customer reported for a new pacemaker implantation, a lead was inserted after the sheath in question was inserted.After the lead reached the right atrium, an attempt was made to peel the sheath away, but the sheath shaft part was torn halfway through the attempt.The sheath was then removed by holding the torn part with forceps.The lead remained in the right atrium, and the procedure was continued and completed without any problems.No health damage was reported.This event is not reportable to pmda.(b)(6) 2024: the customer stated there was no harm to the patient.Patient information provided; initial (b)(6), 72-year-old male.There was no medical or surgical intervention and no procedure delay.

• Brand Name: ADELANTE PEEL-AWAY INTRODUCER SET
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): OSCOR INC.; 4875 palm harbor blvd.; palm harbor 34683
• Manufacturer (Section G): OSCOR INC.; 4875 palm harbor blvd.; palm harbor 34683
• Manufacturer Contact: daniel naut ; 4875 palm harbor blvd.; palm harbor 34683 ; 7279372511
• MDR Report Key: 19505155
• Report Number: 1035166-2024-00064
• Device Sequence Number: 3982658
• Product Code: DYB
• UDI-Device Identifier: 10885672100022
• UDI-Public: 10885672100022
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K073100
• 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): 06/10/2024

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: 06/01/2025
• Device Model Number: AP07016B5
• Device Catalogue Number: AP07016B5
• Device Lot Number: DP-13357
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/28/2024
• Initial Report FDA Received Date: 06/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/18/2021
• 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
• Patient Age: 72 YR
• Patient Sex: Male