MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG SELECTRA EXTENDED HOOK-45; LEAD DELIVERY SYSTEM

Model Number	375527
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	07/14/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The physician reported excessive blood loss during the use of this product, at approximately 100ml of blood.The procedure was completed without any further complication.Should additional information become available this file will be updated.
Additional Manufacturer Narrative
The device is currently not available for analysis.No conclusion can be drawn at this time.No additional information is available at the moment.The file is closed.The investigation will be re-opened should additional data become available.

• Brand Name: SELECTRA EXTENDED HOOK-45
• Common Device Name: LEAD DELIVERY SYSTEM
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• Manufacturer Contact: 6024 jean road; lake oswego, OR 97035 ; 8772459800
• MDR Report Key: 12193473
• Report Number: 1028232-2021-04069
• Device Sequence Number: 11640070
• Product Code: DQY
• UDI-Device Identifier: 04035479116712
• UDI-Public: (01)04035479116712(17)230331(10)7002297684
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K110461
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/31/2023

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: 03/31/2023
• Device Model Number: 375527
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 7002297684
• 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: 07/14/2021
• Supplement Date Received by Manufacturer: 08/31/2023
• Initial Report FDA Received Date: 07/19/2021
• Supplement Report FDA Received Date: 08/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Hospitalization
• Patient Age: 48 YR
• Patient Sex: Male