MAUDE Adverse Event Report: MEDTRONIC MEXICO BROCKENBROUGH¿ NEEDLE; TROCAR

Model Number EP003994S

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Date 04/11/2019

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: 990061-070, lot#: c1-13038.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that during the preparation for an radiofrequency (rf) procedure, the needle "shaved" the inside of the sheath.The products were replaced.There was no patient involvement.

Manufacturer Narrative

Product event summary: the brockenbrough needle, ep003994s with lot number 215947562, was returned and analyzed.Visual inspection of the needle showed that no issue was identified.The reported skiving issue was not confirmed through visual inspection of the product.The needle passed the returned product inspection.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 215947562, was returned and analyzed.Visual inspection of the needle showed that no issue was identified.The reported skiving issue could not be confirmed through testing; 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: 8510636
• MDR Text Key: 141977258
• Report Number: 9612164-2019-01311
• Device Sequence Number: 1
• Product Code: DRC
• UDI-Device Identifier: 00613994663146
• UDI-Public: 00613994663146
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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
• Report Date: 03/17/2020

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 Expiration Date: 08/01/2020
• Device Model Number: EP003994S
• Device Catalogue Number: EP003994S
• Device Lot Number: 215947562
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/11/2019
• Initial Date FDA Received: 04/12/2019
• Supplement Dates Manufacturer Received: 09/27/2019; 03/05/2020
• Supplement Dates FDA Received: 10/14/2019; 03/17/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/02/2018
• 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