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 Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Occupation: other healthcare professional.Pma/510(k) number: pre-amendment.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.

Event Description

It was reported, during an embolization procedure, the tuohy-borst large bore clear plastic sidearm adapter leaked when connected to another manufacturer's catheter.Reportedly, the complaint device would not tighten down on the microcatheter.The back-end leaked.This occurred during prepping and during the procedure.However, the procedure was successfully completed with the device.The patient did not experience any adverse effects as a result of this procedure.No additional interventions were required.This event occurred in three distinct procedures which are reported under medwatch report references: 1820334-2019-00747 and 1820334-2019-00748.Each of these three events occurred on either (b)(6) 2019.The complaint device for this event was discarded at the facility.Reportedly, four unused devices are available to aid in the manufacturer's investigation.

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, unavailable, or unchanged.A review of the complaint history, device history record, manufacturing instructions, drawing, quality control, and specifications were conducted during the investigation.The complaint device was not returned to the manufacturer, however a visual inspection of four returned, unused devices from the same lot did not reveal any damage.The seals of the devices were examined, and none of the devices leaked during testing.There is no evidence to suggest that the devices were not manufactured to specification.Additionally, a document-based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.A review of the device history record showed no nonconforming events which could contribute to this failure mode.It should be noted there were two other reported complaints for this lot number, both reported at the same time and from the same customer as this complaint.Furthermore, a review of the manufacturer¿s instructions, drawing, product labeling, and quality control procedures was conducted, and no gaps were discovered.Labeling does not address this failure mode.Based on the information provided, the examination of the returned product, and the results of our investigation, the cause of this event can be traced to the user and unintended use error.We will continue our monitoring of similar complaints and have notified the appropriate personnel of this event.Per the quality engineering risk assessment, no further action is required.

• 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
• MDR Report Key: 8478902
• MDR Text Key: 140944808
• Report Number: 1820334-2019-00746
• Device Sequence Number: 1
• Product Code: KGZ
• UDI-Device Identifier: 00827002062993
• UDI-Public: (01)00827002062993(17)230919(10)9174778
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 04/25/2019

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 Expiration Date: 09/19/2023
• Device Catalogue Number: PTBYC-RA
• Device Lot Number: 9174778
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/28/2019
• Initial Date FDA Received: 04/03/2019
• Supplement Dates Manufacturer Received: 04/23/2019
• Supplement Dates FDA Received: 04/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1