MAUDE Adverse Event Report: MEDTRONIC MEXICO BROCKENBROUGH NEEDLE; TROCAR

Model Number EP003994S

Device Problem Break (1069)

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

Event Date 09/23/2016

Event Type  malfunction  

Manufacturer Narrative

Product event summary: the lead accessories were returned and analyzed.Product analysis revealed the needle had bends throughout.Suspect needle bent while being advanced through the sheath.Damaged during use.

Event Description

It was reported that following transseptal puncture, the needle and sheath were removed and flushed.A piece of lining from the sheath was flushed out.No patient complications have been reported as a result of this event.

• Brand Name: BROCKENBROUGH NEEDLE
• Type of Device: TROCAR
• Manufacturer (Section D): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer (Section G): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 6158286
• MDR Text Key: 61892232
• Report Number: 9612164-2016-01244
• Device Sequence Number: 1
• Product Code: DRC
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: PRE-AMEND
• 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: 09/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/09/2018
• Device Model Number: EP003994S
• Device Catalogue Number: EP003994S
• Device Lot Number: 211235149
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/23/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/10/2016
• 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