MAUDE Adverse Event Report: MEDTRONIC, INC. SOLOTRAK KR PERCUTANEOUS LEAD INTRODUCER; INTRODUCER, CATHETER

Model Number 6207BTK-1

Device Problems Accessory Incompatible (1004); Break (1069)

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

Event Date 07/30/2019

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 an implant procedure the guidewire did not go through the puncture needle of the introducer.It was noted there was presumably an anomaly of the joint of the needle and the plastic.It was also reported there was a loose/ detached part.The introducer was removed and another product was used to complete the procedure.No patient complications have been reported as a result of this event.

• Brand Name: SOLOTRAK KR PERCUTANEOUS LEAD INTRODUCER
• Type of Device: INTRODUCER, CATHETER
• 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: 8950098
• MDR Text Key: 156118831
• Report Number: 2182208-2019-01587
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00681490142939
• UDI-Public: 00681490142939
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K911236
• 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
• Report Date: 08/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/22/2021
• Device Model Number: 6207BTK-1
• Device Catalogue Number: 6207BTK-1
• Device Lot Number: W4681493
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/01/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/10/2019
• 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