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

Model Number	C304L6906
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	07/07/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product event summary: the catheter was returned with distal tip damaged (nicked and flattened -coded camnlrdd), damaged during procedure.The nicked and flattened distal tip could contribute to insertion issue and catching on tissue/muscle.The shaft was kinked at distance 3 and 3.5 cm.Measured from the proximal end of catheter shaft.Photos taken and saved.There was blood visible on the handle and shaft body.
Event or Problem Description
It was reported that during the implant procedure, the tip of the sheath was quite hard and scratched the patient's cardiac muscle.Another catheter used was too soft and the supporting force was insufficient.Neither lead was implanted.The operation was then aborted for the patient's safety.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
• MDR Report Key: 6920587
• Report Number: 9612164-2017-01380
• Device Sequence Number: 19193577
• Product Code: DQY
• UDI-Device Identifier: 00613994729774
• UDI-Public: 00613994729774
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K033989
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/07/2017

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/24/2018
• Device Model Number: C304L6906
• Device Catalogue Number: C304L6906
• Device Lot Number: 0007952627
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/07/2017
• Initial Report FDA Received Date: 10/06/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other