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

Model Number	C315HIS02
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/01/2020
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 only was aspirating air.The catheter was checked and it was determined that the hemostasis valve was very loose.The catheter was removed and a second catheter was attempted.The valve of the second catheter was tighter than the previous one, but it still did not seal well.The second catheters was not used.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 hemostasis valve of the catheter was damaged.The mechanical operation of the catheter shaft was kinked/buckled.Blood was observed in the hemostasis valve of the delivery catheter.Contrast was observed on the delivery catheter.Blood was observed on the shaft of the delivery catheter.Visual analysis of the lead indicated damage during use.The analyst noted the delivery catheter was returned without the dilator.The delivery catheter shaft is kinked at 6.4 cm.There is blood on the shaft of the delivery catheter at various locations.There is contrast at the distal orifice of the delivery catheter.The blood in the hemostasis valve was soaked in water to remove the blood and the hemostasis valve was found to be torn.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: 9978868
• Report Number: 9612164-2020-01618
• Device Sequence Number: 3070882
• Product Code: DQY
• UDI-Device Identifier: 00613994749925
• UDI-Public: 00613994749925
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: K101885
• 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,Followup
• Report Date (Section B): 06/04/2020

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: 12/08/2021
• Device Model Number: C315HIS02
• Device Catalogue Number: C315HIS02
• Device Lot Number: 0010050542
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2020
• Initial Date Received by Manufacturer: 04/01/2020
• Supplement Date Received by Manufacturer: 06/01/2020
• Initial Report FDA Received Date: 04/20/2020
• Supplement Report FDA Received Date: 06/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 69 YR