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

Model Number	C315HIS02
Medical Device Problem Codes	Break (1069); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/15/2020
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 the catheter snapped during slitting.The catheter was removed and a new one was used without issues.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Product event summary: the delivery catheter was returned and analyzed.The analysis indicated that the catheter did not slit along the score lines.There was an issue with the catheter shaft.The mechanical operation of the catheter slitting showed a spiral slit.Visual analysis of the delivery catheter indicated damage during use.The analyst noted the delivery catheter was returned without the dilator and the slitter.The slit was not on the score line on the hub.The shaft of the delivery catheter was torn at 7 cm.Slitting stopped at 7.5 cm with spiral slitting starting to occur.If information is provided in the future, a supplemental report will be issued.

• Brand Name: DEFLECT
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 10233783
• Report Number: 9612164-2020-02444
• Device Sequence Number: 14010285
• Product Code: DQY
• UDI-Device Identifier: 00613994749925
• UDI-Public: 00613994749925
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K101885
• 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): 07/29/2020

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: 01/13/2022
• Device Model Number: C315HIS02
• Device Catalogue Number: C315HIS02
• Device Lot Number: 0010091619
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2020
• Initial Date Received by Manufacturer: 06/15/2020
• Supplement Date Received by Manufacturer: 07/16/2020
• Initial Report FDA Received Date: 07/06/2020
• Supplement Report FDA Received Date: 07/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Weight: 117