MAUDE Adverse Event Report: OSCOR INC. ADELANTE SAFESHEATH II; INTRODUCER, CATHETER

Model Number AS06013B5

Device Problem Material Too Rigid or Stiff (1544)

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

Event Date 07/27/2023

Event Type  malfunction  

Event Description

The customer reported that a 6f safe sheath failed to split appropriately when being removed post lead insertion.Both sheaths are from the same box and lot number, and both did not split properly and had to be cut by the doctor to be removed.Dr (b)(6) reported that in the last 2 days, 3/4 of the 6f safe sheaths he has used have not split properly.The other sheaths from the same box/lot will be returned for analysis.

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.

• Brand Name: ADELANTE SAFESHEATH II
• Type of Device: 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: 18932307
• MDR Text Key: 338452086
• Report Number: 1035166-2024-00016
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 10885672002241
• UDI-Public: 10885672002241
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122084
• 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: 03/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AS06013B5
• Device Catalogue Number: AS06013B5
• Device Lot Number: DP18303
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/05/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/07/2023
• 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
• Patient Age: 96 YR
• Patient Sex: Female