MAUDE Adverse Event Report: INTEGER HOLDINGS CORPORATION INTRODUCER KIT FOR IMPELLA®; INTRODUCER, CATHETER

Model Number	0052-3025
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Codes	Hematoma (1884); Low Blood Pressure/ Hypotension (1914); Tachycardia (2095)
Date of Event	12/04/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Conclusion not yet available, evaluation in process.A follow-up report will be submitted as soon as the investigation is complete.Integer 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 integer 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, integer, or its employees, caused or contributed to the event described in this report.Nor does this report reflect a conclusion by fda, integer, or its employees, that the report constitutes an admission that the device, integer, or its employees caused or contributed to the event described in this report.
Event or Problem Description
Complaint summary: we have been notified of a complaint involving a oscor intro kit, 14fr x 13 and 25 cm (material #0052-3025, lot # dp-18438)."right groin access was successfully obtained for impella placement.Left groin access attempted next by the interventional cardiologists using a 6 french sheath, however the sheath could not be advanced.The cardiologist removed the sheath from the left side and achieved hemostasis by manual compression.Right groin used for single access pro pci.Pro pci was successfully performed using single right groin access, the impella device provided left ventricular support throughout the procedure.At completion of the procedure the patient developed tachycardic and hypotension.Clinical assessment revealed a left groin hematoma with active bleeding.Hemodynamics stabilised.Vascular surgeon called to assist with left groin bleed.Hemostasis was successfully achieved.Impella was explanted 18.00 once patient was stabilised.Patient was taken to theatres for groin exploration and surgical repair of the left groin." the product return was requested but has not yet been received.
Event or Problem Description
On 26/jan/2026 customer reported; the field rep has stated the product was discarded.
Additional Manufacturer Narrative
The following sections were updated in follow-up 1.B4, d9, d3, g1, g3, g6, h2, h6 & h11.The device has not returned for evaluation, nor were any pictures provided by the customer.Multiple attempts were made to obtain the device, and customer stated the device has been discarded.The customer reported that left groin access attempted next by the interventional cardiologists using a 6 french sheath, however; the sheath could not be advanced.At this time, it is not possible to assign a definitive root cause for the event as reported.The device history records were reviewed to confirm that the device passed all applicable in-process and final inspections.The complaint is non-verifiable as the product was not returned for evaluation.Based on the investigation, a capa is not required as findings did not identify a design, labeling or manufacturing non-conformity.In addition, there was no new failure mode identified, and the risk remains acceptable.The event will be re-evaluated if additional information becomes available.Integer will continue to monitor this event type and risk.Integer 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 integer 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, integer, or its employees, caused or contributed to the event described in this report.Nor does this report reflect a conclusion by fda, integer, or its employees, that the report constitutes an admission that the device, integer, or its employees caused or contributed to the event described in this report.

• Brand Name: INTRODUCER KIT FOR IMPELLA®
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): INTEGER HOLDINGS CORPORATION; 4875 palm harbor blvd.; palm harbor FL 34683
• Manufacturer (Section G): INTEGER HOLDINGS CORPORTATION; 4875 palm harbor blvd.; palm harbor FL 34683
• Manufacturer Contact: mohit malkani ; 4875 palm harbor blvd.; palm harbor, FL 34683 ; 7279372511
• MDR Report Key: 23878907
• Report Number: 1035166-2025-00067
• Device Sequence Number: 18547284
• Product Code: DYB
• UDI-Device Identifier: 00885672009793
• UDI-Public: 00885672009793
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K122084
• 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,Followup
• Report Date (Section B): 03/30/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/01/2026
• Device Model Number: 0052-3025
• Device Catalogue Number: 0052-3025
• Device Lot Number: DP-18438
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/17/2025
• Supplement Date Received by Manufacturer: 03/28/2026
• Initial Report FDA Received Date: 12/23/2025
• Supplement Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/21/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 87 YR
• Patient Sex: Male