MAUDE Adverse Event Report: MEDTRONIC IRELAND SELECTSITE; CATHETER, PERCUTANEOUS

Model Number	C304L6906
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hematoma (1884); Perforation of Vessels (2135)
Date of Event	07/07/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that during implant, the delivery catheter perforated the coronary sinus during lead repositioning and the patient developed a pericardial hematoma.The patient was hemodynamically stable.The patient was treated with intravenous antibiotics and an erythropoiesis-stimulating agent.The patient was hospitalized for an extended period of time.The issue resolved after three weeks.The patient is a participant in a clinical study.No further patient complications have been reported as a result of this event.

• Brand Name: SELECTSITE
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer Contact: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 15385274
• Report Number: 9612164-2022-03339
• Device Sequence Number: 20245902
• Product Code: DQY
• UDI-Device Identifier: 00613994729774
• UDI-Public: 00613994729774
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K033989
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/08/2022

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: 04/03/2024
• Device Model Number: C304L6906
• Device Catalogue Number: C304L6906
• Device Lot Number: 0011150627
• 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: 09/01/2022
• Initial Report FDA Received Date: 09/08/2022
• Date Device Manufactured: 04/04/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: DTMA2QQ CRTD
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention; Hospitalization
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 73 KG