MAUDE Adverse Event Report: ABIOMED, INC. - 1220648 AXILLARY INSERTION INTRODUCER; INTRODUCER, CATHETER (INTRODUCER)

Catalog Number	0052-3006
Medical Device Problem Codes	Crack (1135); Fluid/Blood Leak (1250); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	05/15/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The complainant reported that the cardiovascular surgeon (cvs) placed 23f introducer (from axillary kit) into the graft and placed 2 graft locks.Cvs then cut some of the graft length at this time.Cvs then gained lv access and exchanged the j-wire for the 0.18 abiomed wire.Cvs then proceeded to place impella 5.5, but the cvs did not approve the length of the graft.Soft clamps were placed over the graft and the cvs removed the peel away sheath from the graft over the 0.018 wire and then cut the graft down to his liking.The cvs then advanced the peel away sheath back into the axillary graft.Cvs then advanced the impella 5.5 to the hemostatic valve and initially experienced difficulty advancing through the hemostatic valve but did advance through completely.The soft soft clamp was then removed, and bleeding was noted at the peel away sheath / hemostatic valve and appears cracked.It was also noted that the wire was slightly above the middle of the hemostatic valve.Cvs then removed the impella 5.5 from the graft and reapplied the soft clamps.The cvs then opted to remove the 23 french peel away sheath and exchange it for a new one.A new axillary kit was opened, and new peel away sheath was placed.No further bleeding or issues reported.No patient harm has been reported.
Additional Manufacturer Narrative
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.
Additional Manufacturer Narrative
H6 medical device problem code a01 was inadvertently omitted on the initial manufacturer device report.

• Brand Name: AXILLARY INSERTION INTRODUCER
• Common Device Name: INTRODUCER, CATHETER (INTRODUCER)
• Manufacturer (Section D): ABIOMED, INC. - 1220648; 22 cherry hill drive; danvers MA 01923
• Manufacturer (Section G): ABIOMED, INC.; 22 cherry hill drive; danvers MA 01923
• Manufacturer Contact: derek sammarco ; 22 cherry hill dr.; danvers, MA 01923 ; 7814934967
• MDR Report Key: 25323927
• Report Number: 1220648-2026-08244
• Device Sequence Number: 9986059
• Product Code: DYB
• UDI-Device Identifier: 00885672009755
• UDI-Public: (01)00885672009755(11)250514(10)S9649282
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P140003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/28/2026

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 Catalogue Number: 0052-3006
• Device Lot Number: S9649282
• 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: 05/15/2026
• Supplement Date Received by Manufacturer: 05/15/2026; 07/07/2026
• Initial Report FDA Received Date: 05/28/2026
• Supplement Report FDA Received Date: 06/08/2026; 07/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/14/2025
• 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
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Weight: 113 KG
• Patient Ethnicity: Hispanic