MAUDE Adverse Event Report: MEDTRONIC MEXICO BROCKENBROUGH NEEDLE; TROCAR

Model Number EP003994S

Device Problems Break (1069); Material Fragmentation (1261); Activation, Positioning or Separation Problem (2906); Scratched Material (3020)

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

Event Date 06/21/2018

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: 990061-070.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that during insertion of the needle into the sheath, the trans- septal needle scratched inside the dilator of the sheath and debris was observed on a compress.The needle and sheath were replaced with resolve.No patient complications have been reported as a result of this event.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Product event summary: the needle, ep003994s with lot number 215155804.Visual inspection of the needle showed no physical damage.The outer diameter of the needle was within specification.In conclusion, evidence of skiving was observed, however the device was found to meet manufacturing requirements.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Product event summary: the transseptal needle, (b)(4) with lot number 215155804, was returned and analyzed.No physical damaged can be identified through the visual inspection on the needle.The outer diameter of the needle was within the specification.However, it is plausible that skiving occurred as there is a compatibility issue with the needle and a competitor sheath.The cause of the issue was not established.If information is provided in the future, a supplemental report will be issued.

• 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: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 7742398
• MDR Text Key: 116090921
• Report Number: 9612164-2018-01936
• Device Sequence Number: 0
• Product Code: DRC
• Reporter Country Code: GM
• 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,Followup,Followup,Followup
• Report Date: 03/11/2020
• 2 Devices were Involved in the Event: 1 2

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: 03/27/2020
• Device Model Number: EP003994S
• Device Catalogue Number: EP003994S
• Device Lot Number: 215155804
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/31/2018
• Initial Date FDA Received: 08/02/2018
• Supplement Dates Manufacturer Received: 08/08/2018; 10/18/2018; 02/10/2020
• Supplement Dates FDA Received: 10/02/2018; 10/23/2018; 03/11/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/28/2018
• 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