MAUDE Adverse Event Report: OSCOR INC. INTRODUCER KIT FOR IMPELLA® INTRODUCER, CATHETER

Model Number 0052-3025-JP

Device Problems Fluid/Blood Leak (1250); Material Too Rigid or Stiff (1544); Device Damaged by Another Device (2915)

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

Event Date 08/11/2021

Event Type  malfunction  

Manufacturer Narrative

Conclusion not yet available, evaluation in process. A follow-up will be submitted as soon as the investigation is complete.

Event Description

It was reported that a (b)(6) male underwent a ami/cgs procedure and at the time of the impella insertion, a long 14fr introducer was inserted into the body, and when trying to insert impella, the hemostatic valve was damaged and there was a side leak of blood, so the sheath was to be reinserted. Since it was not possible to pass through the bent part in the sheath, it was decided to issue a new 14fr introducer. There was no delay in the procedure and there was no patient harm reported. The issue was resolved using another introducer.

• Brand Name: INTRODUCER KIT FOR IMPELLA®
• Type of Device: 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 34683 1816
• Manufacturer Contact: doug myers ; 3816 desoto blvd.; palm harbor, FL 34683-1816 ; 7279372511
• MDR Report Key: 12432959
• Report Number: 1035166-2021-00088
• Device Sequence Number: 1
• Product Code: DYB
• 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,Followup
• Report Date: 01/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 0052-3025-JP
• Device Catalogue Number: 0052-3025-JP
• Device Lot Number: DP-12994
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/10/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Age: 56 YR
• Patient Sex: Male
• Patient Weight: KG
• Patient Race: Asian