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

Model Number G06299

Device Problem Fluid/Blood Leak (1250)

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

Event Type  malfunction  

Event Description

As reported, during cardiac and neurological procedures performed in a catheterization lab, twenty-one tuohy-borst large bore clear plastic sidearm adapters would not tighten around 0.014-inch wire guides, resulting in leakage of blood.Per the customer, the 'black rubber grommet' was missing from the devices.The patients did not require any additional procedures due to these occurrences.According to the initial reporter, the patients did not experience any adverse effects due to these occurrences.

Manufacturer Narrative

Device available for evaluation, device evaluated by mfr: the complaint devices will not be returned; however, the customer is returning unused product to cook.Initial reporter occupation = purchasing.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.

Manufacturer Narrative

Summary of event: as reported, during cardiac and neurological procedures performed in a catheterization lab, twenty-one tuohy-borst large bore clear plastic sidearm adapters would not tighten around 0.014-inch wire guides, resulting in leakage of blood.Per the customer, the 'black rubber grommet' was missing from the devices.The patients did not require any additional procedures due to these occurrences.According to the initial reporter, the patients did not experience any adverse effects due to these occurrences.Investigation evaluation: reviews of the complaint history, device history record, manufacturing instructions, quality control procedures, a visual examination and functional test were conducted during the investigation.The complainant returned 59 sealed/unused ptbyc-ra to cook for investigation.Physical testing of the returned devices found that none of them leaked.The complaint was for the device leaking, however, the customer also mentioned that the devices did not tighten enough.After consulting with quality engineering, it was clarified that this device is intended only to seal around a wire guide to prevent leakage.As far as clamping to ¿pin¿ the wire in place, that is not it¿s intended function.This product is not supplied with instructions for use.The device history record for the complaint lot records one relevant non-conformance for ¿screw cap won¿t close¿ on one device.A database search for complaints on the reported lot found no additional lot related complaints from the field.Although this non-conformance was relevant to the reported failure mode, all non-conforming product was scrapped, and there are 100% inspections to capture this non-conformance.Adequate inspection activities have been established, and there are no other lot related complaints that have been received from the field.At this time, cook concluded that no non-conforming product from this lot exists in house or in the field.A review of relevant manufacturing and quality control documents were conducted.Cook has 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 examination of the returned devices suggests that there is evidence the device was manufactured to specification, based on the available information and results of the investigation, cook has concluded that component failure unrelated to manufacturing or design deficiencies contributed to this incident.The customer also noted that these devices lacked a ¿black rubber grommet¿ which their usual tuohy¿s have.However, the complaint device has a clear seal instead and doesn¿t also function to clamp inserted wires into place.The risk analysis for this failure mode was reviewed and no additional escalation is 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.

Event Description

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

• 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: 16183298
• MDR Text Key: 308755335
• Report Number: 1820334-2023-00032
• Device Sequence Number: 1
• Product Code: KGZ
• UDI-Device Identifier: 00827002062993
• UDI-Public: (01)00827002062993(17)270809(10)14886906
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G06299
• Device Catalogue Number: PTBYC-RA
• Device Lot Number: 14886906
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/09/2022
• 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: ABBOTT BALANCE MIDDLEWEIGHT 0.014" X 190CM WIRE; STRYKER SYNCHRO SELECT 0.014" X 215CM WIRE