MAUDE Adverse Event Report: COOK INC FLEXOR RAABE GUIDING SHEATH; DYB INTRODUCER, CATHETER

Model Number N/A

Device Problem Fluid/Blood Leak (1250)

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

Event Date 12/22/2020

Event Type  malfunction  

Manufacturer Narrative

Occupation: territory manager.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, prior to use during a percutaneous biliary drainage procedure, a flexor raabe guiding sheath leaked at the valve.The leak was observed as the device was flushed.The device did not make patient contact.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 new patient or event information to report.

Manufacturer Narrative

Description of event: as reported, prior to use during a percutaneous biliary drainage procedure, a flexor raabe guiding sheath leaked at the valve.The leak was observed as the device was flushed.Investigation ¿ evaluation: a document based investigation was performed including a review of complaint history, device history record, documentation, drawings, the instructions for use, manufacturing instructions, and quality control data.The complaint device was not returned; therefore, no physical examinations could be performed.However, a document based investigation evaluation was performed.There is no evidence to suggest the product was made out of specification.A review of the device history record found one non-conformance related to the reported failure mode.The non-conformance was during leak test on 4 devices.All devices were scrapped and show that the devices were verified for this failure prior to leaving cook.Adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and no other lot related complaints that have been received from the field, it was concluded that there is no evidence that nonconforming product exists in house or in the field.The complaint lot was manufactured to current specifications.A review of complaint history records shows no other complaints associated with the complaint device lot.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: "instructions for use: sheath introduction.Using the side-arm of the valve, flush the sheath y filling the sheath assembly completely with heparinized saline.How supplied upon removal from package, inspect the product to ensure no damage has occurred." capa (b)(4) was previously completed to address this failure mode for valves manufactured at seisa, and the capa included a root cause investigation.The capa team examined the valves to test the potential causes identified.Based on the laboratory investigation, a root cause of inadequate tightening of the cap onto the valve body was identified related to leaking around the silicone disk and through the cap.A fixed span gauge that will measure the distance of the cap to the bottom of the check-flo valves was implemented as a result to ensure that the caps are adequately tightened onto the body of the valves.Design verification testing performed in testing showed that the affected product meets the established acceptance criterion in accordance with iso 11070:1998(e), annex d.No leaks were observed in the test articles during the study.Therefore, the acceptance criterion of the study protocol was met.A review of relevant manufacturing documents was conducted.It was concluded that the device aspect in question was visually/functionally inspected by quality control and no related gaps in production or processing controls were noted.Based on the provided evidence and the completed investigation, cook has concluded the cause could not be confirmed for this incident.Per the quality engineering risk assessment, no further action is warranted.Cook will continue to monitor this device via the complaints database for similar complaints.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

• Brand Name: FLEXOR RAABE GUIDING SHEATH
• Type of Device: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 11100365
• MDR Text Key: 227012615
• Report Number: 1820334-2020-02395
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00827002481879
• UDI-Public: (01)00827002481879(17)230811(10)13360554
• Combination Product (y/n): N
• PMA/PMN Number: K142829
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/11/2023
• Device Model Number: N/A
• Device Catalogue Number: KCFW-4.0-35-55-RB-RAABE
• Device Lot Number: 13360554
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1