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 mechanical operation of the catheter peeling/slitting/splitting showed a spiral slit.The hemostasis valve of the catheter was damaged.The catheter did not peel along the score lines.Visual analysis of the lead indicated damage during use.The analyst noted the delivery catheter was returned without the dilator.The hemostasis valve was still attached to the delivery catheter hub.The slit was not on the score line of the delivery catheter hub.The delivery catheter was spiral slit the entire length of the shaft.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.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
• MDR Report Key: 9931890
• MDR Text Key: 186701936
• Report Number: 9612164-2020-01483
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• PMA/PMN Number: K101885
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• 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: 01/02/2022
• Device Model Number: C315HIS02
• Device Catalogue Number: C315HIS02
• Device Lot Number: 0010077310
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2020
• 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
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1