MAUDE Adverse Event Report: BERLIN HEART GMBH EXCOR®; VENTRICULAR (ASSIST) BYPASS

Model Number	A09-009
Medical Device Problem Code	Scratched Material (3020)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The excor cannula extension set (lot 00133570) was in use on the patient from (b)(6) 2025 until the cannula was replaced on (b)(6) 2025.The event occurred on (b)(6) 2025, which is (36 days) after the extension set was placed on the patient.We have reviewed the device history record (dhr) of the extension set lot no.00133570.This product was produced according to our specifications.According to the production record, a total of 6 extension set with this lot no.Were produced.All extension sets were distributed in the usa and out of six extension sets, five were used on patients.There are no more complaints associated with this lot number except the current complaint.A detailed investigation report will be provided as soon as it is available.
Event or Problem Description
The site contacted berlin heart inc.(bhi) clinical affairs (ca) on (b)(6) 2025 to report a concern for internal scratches on an excor cannula extension set, a09-009 on the patient being supported in lvad configuration on the excor ikus driving unit.Upon reviewing the picture and videos provided by the site, bhi ca recommended the immediate exchange of the affected extension set.Of note, the extension set in the image and videos are noted to be shorter than the recommend length.Bhi ca advised the site to ensure adequate length of the extension when changed.According to the site, the excor blood pump functioned as intended, maintaining complete filling and ejection throughout.The patient had no harm due to the event.
Additional Manufacturer Narrative
The event occurred on (b)(6) 2025, which is 36 days after the extension set in question was placed on the patient, and the extension set continued to remain on the patient for one additional day until it was exchanged on (b)(6) 2025.The affected extension set was returned to berlin heart for examination.Based on the picture provided by the clinic at the time of the event, the reported internal scratches were observed, confirming the reported anomaly.During the external visual inspection of the returned cannula extension set, it was determined that the affected cannula extension set was shortened so much that it fell below the minimum length recommended in the ifu.Due to the cannula extension set being shorter than the recommended minimum length, the flexibility of the cannula wall was severely restricted, leading to increased internal material stresses in the silicone of the cannula wall.In conjunction with the external bending and/or tensile stresses caused by the patient's movements, this most likely led to an incipient fracture.

• Brand Name: EXCOR®
• Common Device Name: VENTRICULAR (ASSIST) BYPASS
• Manufacturer (Section D): BERLIN HEART GMBH; wiesenweg 10; berlin, 12247 ; GM 12247
• Manufacturer (Section G): BERLIN HEART GMBH; wiesenweg 10; berlin, 12247 ; GM 12247
• Manufacturer Contact: mary beth tate ; 9391 grogan's mill road; suite a-6; the woodlands, TX 77380 ; 7347092080
• MDR Report Key: 23658434
• Report Number: 3004582654-2025-00066
• Device Sequence Number: 15959391
• Product Code: DSQ
• UDI-Device Identifier: 04260090040171
• UDI-Public: (01)04260090040171(17)260630(10)00133570
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P160035
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 01/13/2026

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 Expiration Date: 06/30/2026
• Device Model Number: A09-009
• Device Lot Number: 00133570
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/05/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/26/2025
• Supplement Report FDA Received Date: 01/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/31/2023
• 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
• Patient Age: 8 YR
• Patient Sex: Male
• Patient Weight: 17 KG