MAUDE Adverse Event Report: COOK INC PERFORMER CHB GUIDING SHEATH; DYB INTRODUCER, CATHETER

Model Number G11936

Device Problems Material Puncture/Hole (1504); Material Separation (1562)

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

Event Type  malfunction  

Manufacturer Narrative

Pma/510(k) number: pre-amendment.Device evaluated by mfg: device evaluation has begun; however, a conclusion is not yet available.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 preparation of the device prior to use, the dilator included in a performer chb guiding sheath appeared to perforate the sheath upon insertion of the dilator into the sheath.A new device was opened and used to successfully complete the unknown procedure.Upon return and initial evaluation of the complaint device, the dilator was noted to exit the sheath hub alongside the sheath.The sheath material was not noted to be damaged.

Manufacturer Narrative

Summary of event: as reported, during preparation of the device prior to use, the dilator included in a performer chb guiding sheath appeared to perforate the sheath upon insertion of the dilator into the sheath.A new device was opened and used to successfully complete the unknown procedure.Investigation evaluation: reviews of the complaint history, device history record, drawing, instructions for use (ifu), manufacturing instructions, and quality control procedures were conducted during the investigation.A visual inspection of the complaint device was also conducted.One performer chb guiding sheath was received in prior to use condition.The dilator was coming out of the check-flo assembly, alongside the sheath instead of inside the sheath.Initially, the sheath did not appear damaged; however, when the check-flo assembly was taken apart, a hole was discovered just below the flare of the sheath, where the dilator was passing through.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 product ifu states: "upon removal from package, inspect the product to ensure no damage has occurred." the investigation of the returned device and communication with production suggests that the complaint device was manufactured out of specification.A subsequent review of all devices built by the applicable operator within the same timeframe as the complaint lot revealed no relevant non-conformances or related complaints.Therefore, there is no evidence that additional non-conforming devices from the complaint lot exist in-house or in the field.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 manufacturing deficiencies contributed to this incident.The appropriate personnel were retrained to prevent this failure from occurring again in the future.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.

Event Description

Upon further evaluation and hub dissection of the complaint device, the sheath material was found to have a hole just below the flare, allowing passage of the dilator through the hole.

• Brand Name: PERFORMER CHB GUIDING SHEATH
• Type of Device: DYB INTRODUCER, 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: 13367836
• MDR Text Key: 290161499
• Report Number: 1820334-2022-00129
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00827002119369
• UDI-Public: (01)00827002119369(17)231204(10)13606883
• 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: 03/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/04/2023
• Device Model Number: G11936
• Device Catalogue Number: RCFW-4.0-25-45-RB-CHB
• Device Lot Number: 13606883
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2022
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/03/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/04/2020
• 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