MAUDE Adverse Event Report: MEDTRONIC, INC. DEFLECT; CATHETER, PERCUTANEOUS

Model Number C315HIS02

Device Problems Mechanical Problem (1384); Detachment of Device or Device Component (2907); Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/18/2020

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, the hemostatic valve of the catheter was not cut at the time of slitting.This resulted in the lead being pulled with the catheter and dislodging.The lead and catheter were removed and a second lead was used with a new catheter.The same issue occurred during slitting which resulted in the second lead dislodging.It was further reported that both leads had developed kinks during slitting.It was suspected that reason the slitter was not cutting was that the hemostatic valve had been bonded to the incorrect location or that it had been insufficiently bonded to the catheter.The second lead and catheter were removed and replaced.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.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 with the slitter and two leads (lff283531v and lff283555v).The slit did not start on the score line.The hub was spiral slit and did not continue on the score line.Slitting stopped at 8 cm from the proximal end of the delivery catheter.There were no anomalies found with the hemostasis valve and the hemostasis valve bonding.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.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, INC.; 8200 coral sea street ne; mounds view MN 55112
• MDR Report Key: 10246271
• MDR Text Key: 197981309
• Report Number: 2182208-2020-01237
• 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: 07/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2020
• 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: 0010190556
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2020
• Date Manufacturer Received: 07/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1