MAUDE Adverse Event Report: ABIOMED, INC. - 1220648 KIT, 14FR INTRODUCER, 13CM&25CM, STERILE; INTRODUCER, CATHETER (SHEATH)

Catalog Number	0052-3046
Medical Device Problem Codes	Crack (1135); Fluid/Blood Leak (1250); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	02/25/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A4 weight is unknown.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by abiomed inc, or its employees that the report constitutes an admission that the product, abiomed inc, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
Clinical review/rationale: an impella cp was inserted via the 14fr sheath at the femoral artery to support the 78 year old male patient who had been admitted in with the indication of a protected coronary angioplasty, for the known coronary artery disease.The 14fr introducer was seen to be bleeding.The sheath was removed due to the blood loss and was seen to have a crack.The team placed a new introducer and support proceeded.The impella system was explanted after the coronary angioplasty.No blood products were infused and no other intervention was shared.The patient survived the event.
Event or Problem Description
Clinical narrative(updated): an impella cp was inserted via a 14fr sheath at the femoral artery to support a 78-year-old male patient admitted for protected coronary angioplasty with known coronary artery disease.During the procedure, the 14fr introducer was observed to be bleeding.The sheath was removed due to blood loss and was found to have a visible crack in the head.The team placed a new introducer and support proceeded.The bleed was likely a result of the physician re-inserting the dilator after the sheath was already in the body in an attempt to advance it further, at which point the sheath itself started bleeding.The new sheath resolved all bleeding.The impella system was explanted after the coronary angioplasty.The patient survived the event.Bleeding may be attributed to access-site complications and procedural technique, specifically the re-insertion of the dilator after sheath placement, resulting in sheath damage and subsequent blood loss.
Additional Manufacturer Narrative
B5, d4 udi, and h6 medical device problem code corrected.

• Brand Name: KIT, 14FR INTRODUCER, 13CM&25CM, STERILE
• Common Device Name: INTRODUCER, CATHETER (SHEATH)
• Manufacturer (Section D): ABIOMED, INC. - 1220648; 22 cherry hill drive; danvers MA 01923
• Manufacturer (Section G): OSCOR CARIBE LLC; zona franca las americas; autopista las americas km 22; santo domingo ; DO
• Manufacturer Contact: derek sammarco ; 22 cherry hill drive; danvers, MA 01923 ; 7814934967
• MDR Report Key: 24530503
• Report Number: 1220648-2026-04604
• Device Sequence Number: 10350894
• Product Code: DYB
• UDI-Device Identifier: 00813502013269
• UDI-Public: (01)00813502013269(11)250410(10)S9652838
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 0052-3046
• Device Lot Number: S9652838
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2026
• Supplement Date Received by Manufacturer: 04/10/2026
• Initial Report FDA Received Date: 03/06/2026
• Supplement Report FDA Received Date: 04/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/10/2025
• 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: 78 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White