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

Model Number C315HIS02

Device Problem Mechanical Problem (1384)

Patient Problem Blood Loss (2597)

Event Date 09/29/2019

Event Type  malfunction  

Manufacturer Narrative

Product event summary: the delivery catheter was returned and analyzed.No anomalies were found.The mechanical operation of the catheter shaft was kinked.The mechanical operation of the catheter slitting showed a spiral slit.The catheter did not slit along the score lines.There was an issue with the hemostasis valve.Visual analysis indicated damage during use.The analyst noted that a cut is visible on the hemostasis valve.It was cut at the time of slitting the catheter.Otherwise, no anomalies were found on the hemostasis valve.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that during the procedure, the patient experienced a lot of bleeding when the guiding catheter was inserted.The hemostasis valve was supposed to stop the bleeding.The bleeding continued through the procedure but the catheter was used as it was.It was suspected that the hemostasis valve was loose on the catheter.The catheter was removed.No further patient complications have been reported as a result of this event.

• Brand Name: DEFLECT
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer Contact: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 9203215
• MDR Text Key: 166273349
• Report Number: 9612164-2019-04408
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K101885
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/23/2019

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
• Device Operator: Health Professional
• Device Model Number: C315HIS02
• Device Catalogue Number: C315HIS02
• Device Lot Number: 0009803619
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/29/2019
• Initial Date FDA Received: 10/17/2019
• Supplement Dates Manufacturer Received: 10/21/2019
• Supplement Dates FDA Received: 10/23/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 75 YR