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

Model Number C315HIS02

Device Problem Mechanical Problem (1384)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/17/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that during the implant procedure, while slitting of the catheter was performed, it was noted the slitter and the lead had deviated from their positions in the catheter and the hemostasis valve of the catheter had come off.The slitter was unable to advance as intended.The valve was cut out using forceps and the catheter was replaced.Another attempt for implanting the lead was made but advancing the slitter was not smooth.At the time of slitting the hemostasis valve came off and the slitter did not advance as intended.The catheter was removed and replaced with a different catheter, and the lead was implanted to complete the procedure.No patient complications have been reported as a result of this event.

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 hemostasis valve of the catheter.The hemostasis valve of the catheter was damaged.The mechanical operation of the catheter peeling/slitting/splitting showed a spiral slit.Visual analysis of the delivery catheter indicated damage during use.The analyst noted the full delivery catheter was returned without the dilator.The hemostasis valve was damaged and was dislodged of the delivery catheter hub.The slit was not on the score line of the delivery catheter hub.The delivery catheter was spiral slit down to 20.6 cm from the proximal end of the delivery catheter where the slitting discontinued.If information is provided in the future, a supplemental report will be issued.

• 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: 9931875
• MDR Text Key: 186673088
• Report Number: 9612164-2020-01482
• 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: 04/22/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 11/18/2021
• Device Model Number: C315HIS02
• Device Catalogue Number: C315HIS02
• Device Lot Number: 0010022794
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/17/2020
• Initial Date FDA Received: 04/07/2020
• Supplement Dates Manufacturer Received: 04/22/2020
• Supplement Dates FDA Received: 04/22/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/19/2019
• 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