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

Model Number	G12664
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/30/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
As reported, prior to patient contact during a "tase" procedure, a hole or separation was noted between the performer introducer sheath and hub.As the user attempted to insert the dilator, it did not enter the lumen of the sheath, but rather came out between the hub and sheath material.The device did not make contact with the patient, and another device was used to successfully complete the procedure.There was no impact to the patient.
Event or Problem Description
No new patient or event information to report.
Additional Manufacturer Narrative
Description of event: as reported, prior to patient contact during a "tase" procedure, a hole or separation was noted between the performer introducer sheath and hub.As the user attempted to insert the dilator, it did not enter the lumen of the sheath, but rather came out between the hub and sheath material.The device did not make contact with the patient, and another device was used to successfully complete the procedure.There was no impact to the patient.Investigation ¿ evaluation a visual inspection of the returned device was conducted.A document based investigation was also performed including a review of complaint history, device history record, documentation, drawings, the instructions for use, manufacturing instructions, and quality control data.The complainant returned (b)(4).Prior to use to cook for investigation.Physical examination of the returned device showed: one prior to use sheath and dilator were returned.Dilator was partially inserted through sheath.Half of dilator exited the junction between connector cap and sheath.Proximal fitting was disassembled, and the flare was malformed with half of it missing.A review of the device history record found no non-conformances related to the reported failure mode.Because 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 that have been received from the field, it was concluded that there is no evidence that nonconforming product exists in house or in field.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: how supplied "upon removal from package, inspect the product to ensure no damage has occurred." 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 device failure contributed to 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: PERFORMER INTRODUCER
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 10975463
• Report Number: 1820334-2020-02264
• Device Sequence Number: 16941332
• Product Code: DYB
• UDI-Device Identifier: 00827002126640
• UDI-Public: (01)00827002126640(17)230612(10)13199785
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/17/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/12/2023
• Device Model Number: G12664
• Device Catalogue Number: RCFN-4.0-18-MPIS-NT
• Device Lot Number: 13199785
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/31/2020
• Initial Date Received by Manufacturer: 12/01/2020
• Supplement Date Received by Manufacturer: 04/27/2021
• Initial Report FDA Received Date: 12/09/2020
• Supplement Report FDA Received Date: 05/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 2 YR
• Patient Weight: 11