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

Catalog Number TSNC-18-71.0

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Pma/510(k) number = exempt.This event has been reported to the fda, per the reporter, under medsun report: b)(4).This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.

Event Description

As reported, cook transseptal needles have scored the inside of another manufacturer's sheath during unknown procedures, resulting in plastic shavings coming out of the sheaths upon flushing.There has been no harm reported to any patient.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Description of event: as reported, cook transseptal needles have scored the inside of another manufacturer's sheath during unknown procedures, resulting in plastic shavings coming out of the sheaths upon flushing.There has been no harm reported to any patient.Investigation ¿ evaluation.A visual inspection and inspection of unused product of the returned device was conducted.A document based investigation was also performed including a review of complaint history, device history record, drawings, manufacturing instructions, quality control data, and specifications.The complainant returned one open needle and additional sealed devices from other lots to cook for investigation.Physical examination of the returned device showed: one open tsnc needle was received along with 28 sealed devices from various lots.Inspection of the opened needle found that it was not damaged, as the back bevel was present.The sealed devices were examined, and no damage was noted.The back bevel was also present on all unopened devices.At this time, cook concluded that the returned devices were manufactured within specification.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: instructions for use: ¿4.Flush the transseptal needle and introduce the obturator, which will prevent damage to or puncture of the introducer during introduction of the needle.¿ how supplied: ¿supplied sterilized by ethylene oxide gas in peel-open packages.Intended for one-time use.Sterile if package is unopened or undamaged.Do not use the product if there is doubt as to whether the product is sterile.Store in a dark, dry, cool place.Avoid extended exposure to light.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 a component failure contributed to this incident.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.

Event Description

No new patient or event information to report.

• Brand Name: TRANSSEPTAL NEEDLE
• Type of Device: DRC TROCAR
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 11108931
• MDR Text Key: 258582044
• Report Number: 1820334-2021-00002
• Device Sequence Number: 1
• Product Code: DRC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 03/03/2021

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
• Device Operator: Health Professional
• Device Catalogue Number: TSNC-18-71.0
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2021
• Initial Date Manufacturer Received: 12/21/2020
• Initial Date FDA Received: 01/04/2021
• Supplement Dates Manufacturer Received: 02/18/2021
• Supplement Dates FDA Received: 03/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BAYLIS TORFLEX 8.5 FR