COOK BRAND TRANSEPTAL NEEDLE REF #TSNC-18-71.0/G02364

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-16 for COOK BRAND TRANSEPTAL NEEDLE REF #TSNC-18-71.0/G02364 manufactured by Cook, Inc..

Event Text Entries

[142461381] The 2 cooks trans-septal needles from this lot would not pass through the sheath (2 different sheaths attempted). When they tried a new needle lot, it worked fine. There was no harm to the pt. The defective lot appears to have a different curvature. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5085939
• MDR Report Key: 8523190
• Date Received: 2019-04-16
• Date of Report: 2019-04-12
• Date of Event: 2019-04-02
• Date Added to Maude: 2019-04-17
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Sequence Number: 1

• Brand Name: COOK BRAND TRANSEPTAL NEEDLE
• Generic Name: TROCAR
• Product Code: FBQ
• Date Received: 2019-04-16
• Model Number: REF #TSNC-18-71.0/G02364
• Lot Number: 9227509
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: COOK, INC.

Device Sequence Number: 2

• Brand Name: COOK BRAND TRANSEPTAL NEEDLE
• Generic Name: TROCAR
• Product Code: FBQ
• Date Received: 2019-04-16
• Model Number: REF #TSNC-18-71.0/G02364
• Lot Number: 9227509
• Operator: HEALTH PROFESSIONAL
• Device Availability: *
• Device Eval'ed by Mfgr: I
• Device Sequence No: 2
• Device Event Key: 0
• Manufacturer: COOK, INC.
• Manufacturer Address: US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2019-04-16