MAUDE Adverse Event Report: SORIN GROUP ITALIA STOCKERT A272 SERIES PEDIATRIC AORTIC CANNULAE; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Catalog Number	A272-40N
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Sorin group italia received a report that, after cannulated while snaring the cannulae, surgeon noticed the tip was crack.The moment surgeon took out the cannulae, the tip chipped into pieces outside of patient.There is no report of any patient injury.
Additional Manufacturer Narrative
A.1.-a.5.Patient information was not provided.H.11.Sorin group italia manufactures the stockert a272 series pediatric aortic cannulae.According to customer, this is the second cannulae was found cracked a photographic evidence of the complained cannula was provided.The first cannulae was a different size and was identified during set up.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Additional Manufacturer Narrative
H11: a device history record (dhr) review was conducted, and no deviations related to the alleged defect were found.Review of the complaints database showed no other similar case notified for the noticed batch, out of 100 manufactured units, nor a concerning adverse trend was identified for this kind of failure.Based on the collected information, it is likely that an initial micro-crack was originated on the tip during transport after product release, due to rough handling / accidental impact of the device package.In addition, considering that complained tip is manually bent to the proper angle during manufacturing, it cannot be excluded either that the initial micro-crack was created during this phase.Likely, the crack further grew and propagated due to mechanical stresses during use, resulting in the reported break.To prevent re-occurrence, the manufacturing personnel has been involved in a dedicated training meeting to discuss the specific event.No adverse trend have been identified and the risk is low and acceptable.
Event or Problem Description
See initial report.

• Brand Name: STOCKERT A272 SERIES PEDIATRIC AORTIC CANNULAE
• Common Device Name: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP ITALIA; strada statale 12 nord, 86; mirandola
• Manufacturer (Section G): SORIN GROUP ITALY; via statale 12 nord 86; mirandola 41037 ; IT 41037
• Manufacturer Contact: antonella donatiello ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 21262194
• Report Number: 9680841-2025-00004
• Device Sequence Number: 19917446
• Product Code: DWF
• UDI-Device Identifier: 08033178004633
• UDI-Public: (01)08033178004633(17)260730(10)2307310051(240)A272-40N
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: K002273
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/21/2025

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 Expiration Date: 07/30/2026
• Device Catalogue Number: A272-40N
• Device Lot Number: 2307310051
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/02/2025
• Supplement Date Received by Manufacturer: 07/24/2025
• Initial Report FDA Received Date: 01/29/2025
• Supplement Report FDA Received Date: 08/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/30/2023
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown