MAUDE Adverse Event Report: COOK INC TRANSSEPTAL NEEDLE; DRC TROCAR

Model Number	G02364
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/18/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Occupation: radiology tech.Pma/510(k) number = exempt.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.
Event or Problem Description
As reported, prior to patient contact during a cardiac ablation procedure, an unknown orange fluid and particulate came out of a transseptal needle upon flushing the device.The device did not make patient contact.A new device was used to complete the procedure.There has been no report that the patient required any additional procedures or experienced any adverse effects due to this event.
Event or Problem Description
No new patient or event information to report.
Additional Manufacturer Narrative
Description of event: as reported, prior to patient contact during a cardiac ablation procedure, an unknown orange fluid and particulate came out of a transseptal needle upon flushing the device.The device did not make patient contact.A new device was used to complete the procedure.Investigation ¿ evaluation a visual inspection of the returned device was conducted.A document based investigation was also performed including a review of complaint history, device history record, documentation, drawings, the instructions for use, manufacturing instructions, and quality control data.The complainant returned one tsnc-18-71.0 needle.Physical examination of the returned device showed a slight discoloration potentially corrosion at the tip of needle was noticed.The needle was flushed, no particulate or residue was present.Additional device analysis was performed on 17nov2020, a blood test was performed on the device to see if blood was present on the device, the device was negative for blood.A review of the device history record found no non-conformances related to the reported failure mode.Because there are no related non-conformances, adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and no other lot related complaints that have been received from the field, it was concluded that there is no evidence that nonconforming product exists in house or in field.A review of complaint history records shows no other complaints associated with the complaint device lot.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: device description ¿the transseptal needle set consists of a transseptal needle and obturator.¿ needle introduction ¿4.Flush the transseptal needle and introducer the obturator, which will prevent damage to or puncture of the introducer during introduction of the needle.¿ how supplied ¿upon removal from package, inspect the product to ensure no damage has occurred." a review of relevant manufacturing documents was conducted.It was concluded that the device aspect in question was visually/functionally inspected by quality control and no related gaps in production or processing controls were noted.Cook has concluded that a manufacturing deficiency most likely contributed to this event.It is believed that the flux used in the manufacturing of the needle was not properly cleaned off in the ultrasonic bath, which damaged the stainless steel layer on the surface of the needle.The damaged needle surface then became corroded and discolored when the device was flushed with saline.Retraining was completed for the assembler responsible for cleaning the needle in the ultrasonic bath after the flux is used.As this complaint is the only complaint reported on this lot and there are no related non-conformances, it is believed that this is an isolated incident and there is no evidence that other products in house or in the field are affected.Per the quality engineering risk assessment, no further action is warranted.Cook will continue to monitor this device via the complaints database for similar complaints.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

• Brand Name: TRANSSEPTAL NEEDLE
• Common Device Name: DRC TROCAR
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 10453357
• Report Number: 1820334-2020-01561
• Device Sequence Number: 4060092
• Product Code: DRC
• UDI-Device Identifier: 00827002023642
• UDI-Public: (01)00827002023642(17)250528(10)13216496
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/23/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/28/2025
• Device Model Number: G02364
• Device Catalogue Number: TSNC-18-71.0
• Device Lot Number: 13216496
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2020
• Initial Date Received by Manufacturer: 08/18/2020
• Supplement Date Received by Manufacturer: 03/15/2021
• Initial Report FDA Received Date: 08/26/2020
• Supplement Report FDA Received Date: 03/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1