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

Model Number	C315HIS02
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2020
Type of Reportable Event	Malfunction
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 the implant procedure, the catheter sheath broke due to a long procedure time.It was noted that the sheath was used due to the patient¿s myocardium and the physician found many suitable positions, but they all were unsuccessful.The catheter was replaced with another catheter.No patient complications have been reported as a result of this event.

• Brand Name: DEFLECT
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• MDR Report Key: 10905120
• Report Number: 9612164-2020-04609
• Device Sequence Number: 2713568
• Product Code: DQY
• UDI-Device Identifier: 00613994749925
• UDI-Public: 00613994749925
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K101885
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/25/2020

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: 07/10/2022
• Device Model Number: C315HIS02
• Device Catalogue Number: C315HIS02
• Device Lot Number: 0010305981
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/10/2020
• Initial Report FDA Received Date: 11/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 58 YR