MAUDE Adverse Event Report: COOK INC TUOHY-BORST LARGE BORE CLEAR PLASTIC SIDEARM ADAPTER; KGZ ACCESSORIES, CATHETER

Catalog Number PTBYC-RA

Device Problem Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/04/2022

Event Type  malfunction  

Event Description

As reported, during a y-90 procedure and using a tuohy-borst large bore clear plastic sidearm adapter, the adapter leaked significantly when attached to the microcatheter.No unintended section of the device remained inside of the patient's body.No additional procedures were required due to the occurrence.No adverse effects were reported due to the occurrence.Additional event and patient information has been requested.

Manufacturer Narrative

Concomitant products: boston sci prograte microcatheter or penumbra green lantern microcatheter use on (b)(6) 2022.Occupation: lead tech ir.Pma/510k #: exempt.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Manufacturer Narrative

1820334-2022-00741-1 as reported, during a y-90 procedure and using a tuohy-borst large bore clear plastic sidearm adapter, the adapter leaked from the "the top" significantly when attached to the microcatheter.No unintended section of the device remained inside of the patient's body.No additional procedures were required due to the occurrence.No adverse effects were reported due to the occurrence.Additional information: b5, d4: (potential lot numbers: 10069195, 14252977, 14565135, and 14647572) investigation evaluation: reviews of the complaint history, device history record, drawing, manufacturing instructions, and quality control procedures were conducted during the investigation.The complaint device was not returned to cook for investigation.The complaint lot was not provided, however, a sales history search found 4 potential lot numbers.A device history search found no relevant non-conformances for these device lots.A complaint history search revealed 2 potentially relevant complaints on one of the lots for a similar failure mode.However, since there was no manufacturing deficiency discovered for either complaint, and none of the lots have relevant non-conformances, cook has determined that no non-conforming product exists in house or in the field.The information provided upon review of complaint file, dhr, and dmr provide objective evidence to support that the device was manufactured to specification.Cook concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.Based upon the available information and results of the investigation, cook has concluded that component failure unrelated to the design or manufacturing of the complaint device caused this incident.The appropriate personnel have been notified and cook will continue to monitor for similar events.Per the quality engineering risk assessment, no further action is required.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

Additional information received 12aug2022.The leak was noted at the "top of the tuohy." an unspecified.014 wire was used during the procedure.

• Brand Name: TUOHY-BORST LARGE BORE CLEAR PLASTIC SIDEARM ADAPTER
• Type of Device: KGZ ACCESSORIES, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 14436954
• MDR Text Key: 292507254
• Report Number: 1820334-2022-00741
• Device Sequence Number: 1
• Product Code: KGZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/02/2022

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: PTBYC-RA
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/09/2022
• Initial Date FDA Received: 05/19/2022
• Supplement Dates Manufacturer Received: 08/12/2022
• Supplement Dates FDA Received: 09/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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