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

Model Number	C304-HIS
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product event summary: the delivery catheter was returned and analyzed.Analysis indicated that the mechanical operation of the catheter slitting showed a spiral slit.The catheter did not peel along the score lines.Visual analysis of the lead indicated damage during use.If information is provided in the future, a supplemental report will be issued.
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 a lead implant procedure, the physician experienced extreme difficulty slitting through the catheter.The slitting was completed and the catheter was removed.No 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
• MDR Report Key: 9257154
• Report Number: 9612164-2019-04550
• Device Sequence Number: 11413104
• Product Code: DQY
• UDI-Device Identifier: 00763000147006
• UDI-Public: 00763000147006
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K183493
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/15/2019

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: 06/25/2021
• Device Model Number: C304-HIS
• Device Catalogue Number: C304-HIS
• Device Lot Number: 0009803477
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2019
• Initial Date Received by Manufacturer: 10/11/2019
• Supplement Date Received by Manufacturer: 11/11/2019
• Initial Report FDA Received Date: 10/30/2019
• Supplement Report FDA Received Date: 11/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 29 YR