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

Concomitant medical products: product id: c315his02, lot#: 0010190556.Product id: 383069, serial#: (b)(4), implanted: (b)(4) 2020, explanted: (b)(6) 2020.Product id: 383069, serial#: (b)(4), implanted: (b)(6) 2020, explanted: (b)(6) 2020.Product id: w2dr01, serial#: (b)(4), implanted: (b)(6) 2020.Product id: 5076-45, serial# (b)(4), implanted: (b)(6) 2020.Product id: 6232adj, lot#: 46131819.Product id: 6232adj, lot#: 46131819.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.

• Brand Name: DEFLECT
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer (Section G): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer Contact: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 10246321
• MDR Text Key: 199441547
• Report Number: 2182208-2020-01238
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/08/2020

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 Model Number: C315HIS02
• Device Catalogue Number: C315HIS02
• Device Lot Number: 0010190556
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/18/2020
• Initial Date FDA Received: 07/08/2020
• 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