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

Catalog Number PTBYC-RA

Device Problem Fluid/Blood Leak (1250)

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

Event Type  malfunction  

Event Description

As reported, during unspecified procedures in neuro interventional radiology, two tuohy-borst large bore clear plastic sidearm adapters leaked and would not maintain hemostasis.One additional device leaked during testing by the cook sales representative.The devices were used with an unspecified 5-french catheter and another manufacturer's 0.035-inch wire guide.Resistance was not encountered upon advancement of the wire guide through the valve; however, although the connection and ports are "fine", resistance was encountered as the device was tightened around the wire, and the device "squeaked".The procedures were completed successfully by holding pressure around the valves.No intervention was required to treat blood loss, and there have been no adverse effects to any patient.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.D9, h3: the complaint device(s) will not be returned, however, additional stock will be returned for investigation.E1: customer name and address = postal code: (b)(6).E3: occupation = manager.G4: 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.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

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Summary of event: as reported, during unspecified procedures in neuro interventional radiology, two tuohy-borst large bore clear plastic sidearm adapters leaked and would not maintain hemostasis.One additional device leaked during testing by the cook sales representative.The devices were used with an unspecified 5-french catheter and another manufacturer's 0.035-inch wire guide.Resistance was not encountered upon advancement of the wire guide through the valve; however, although the connection and ports are "fine", resistance was encountered as the device was tightened around the wire, and the device "squeaked".The procedures were completed successfully by holding pressure around the valves.No intervention was required to treat blood loss, and there have been no adverse effects to any patient.Investigation evaluation: reviews of the complaint history, device history record (dhr), and quality control procedures were conducted during the investigation.A visual inspection and functional test of a prior-to-use device from the lot, returned by the customer, was also conducted.The customer returned one prior-to-use device, from the same lot as the complaint devices, to cook for investigation.No difficulties were encountered when screwing the valve closed.Squeaking was not heard.After the valve was closed, the device was leak tested with a 0.038-inch wire inserted.The device did not leak.A document-based investigation evaluation was performed.A review of the device history record found no relevant non-conformances on the lot.A review of complaint history found no additional complaints for this lot number.A review of the device master record (dmr) concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.The information provided upon review of the dmr, dhr, and investigation of the prior-to-use device from the same lot as the complaint devices suggests that there is evidence the devices were manufactured to specification.There is no evidence of non-conforming devices in-house or in the field.Based on the information provided and the results of the investigation, cook has concluded that a component failure, unrelated to manufacturing or design deficiencies, contributed to this event.The risk analysis for this failure mode was reviewed and no additional escalation was required.The appropriate personnel have been notified and cook will continue to monitor for similar events.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.

• 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: 17801429
• MDR Text Key: 324166043
• Report Number: 1820334-2023-01277
• Device Sequence Number: 1
• Product Code: KGZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2023
• 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: 15520736
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/16/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/06/2023
• 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
• Treatment: TERUMO 0.035 GLIDEWIRE STANDARD.