MAUDE Adverse Event Report: MULTI-SIDEPORT DUAL CHECK VALVE CATHETER INFUSION SET; DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC

Catalog Number MCIS-5.0-35-130-20.0

Device Problem Crack (1135)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/11/2020

Event Type  malfunction  

Manufacturer Narrative

Customer name and address= phone: (b)(6).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

As reported, during an unspecified procedure involving occlusion of a prosthesis, a multi-sideport dual check valve catheter infusion set leaked.The catheter was installed inside of a prosthesis according to usual technique for infusion of a thrombolytic agent.A solution of rtpa diluted in saline was prepared and a pulse spray was started.From the beginning to middle of the procedure, a leak was noted in the y-fitting.A longitudinal crack was observed from the outer to inner edge.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

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 an unspecified procedure involving occlusion of a prosthesis, a multi-sideport dual check valve catheter infusion set leaked.The catheter was installed inside of a prosthesis according to usual technique for infusion of a thrombolytic agent.A solution of rtpa diluted in saline was prepared and a pulse spray was started.From the beginning to middle of the procedure, a leak was noted in the y-fitting.A longitudinal crack was observed from the outer to inner edge.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Investigation evaluation: reviews of the complaint history, device history record, drawing, instructions for use (ifu), manufacturing instructions, quality control, and specifications were conducted during the investigation.The complaint device was not returned to cook for investigation.A document-based investigation evaluation was performed.No related non-conformances were found, and there have been no other reported complaints for this lot number.The information provided upon review of complaint file, device history record, complaint history, and device master record provide objective evidence to support that the device was manufactured to specification.As 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 have been received from the field, it was concluded that there is no evidence that nonconforming product exists in-house or in field.The product ifu states: ¿do not use a power injector with the dual check valve.Damage to the dual check valve may occur.¿ the ifu also instructs: ¿upon removal from package, inspect the product to ensure no damage has occurred.¿ cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.Based on the information provided and the results of the investigation, cook has concluded that a component failure contributed to this incident.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: MULTI-SIDEPORT DUAL CHECK VALVE CATHETER INFUSION SET
• Type of Device: DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC
• MDR Report Key: 11089982
• MDR Text Key: 227014218
• Report Number: 1820334-2020-02376
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 10827002087047
• UDI-Public: (01)10827002087047(17)221231(10)10201649
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other
• Type of Report: Initial,Followup
• Report Date: 04/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2022
• Device Catalogue Number: MCIS-5.0-35-130-20.0
• Device Lot Number: 10201649
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/01/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/31/2019
• 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
• Patient Age: 37 YR