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

Model Number G11672

Device Problems Device Contamination with Chemical or Other Material (2944); Packaging Problem (3007)

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

Event Date 01/19/2021

Event Type  malfunction  

Manufacturer Narrative

Occupation: other non-healthcare professional: inventory analyst pma/510k #: preamendment.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, there were small white particles within the packaging the performer introducer device.It was also noted that the device was packaged differently than normal.The dilator was not in the sheath but was packaged separately within the set.No adverse effects were reported related to this occurrence.

Event Description

No new patient or event information to report.

Manufacturer Narrative

Description of event: as reported, there were small white particles within the packaging the performer introducer device.It was also noted that the device was packaged differently than normal.The dilator was not in the sheath but was packaged separately within the set.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, drawings, the instructions for use, manufacturing instructions, quality control data, and trends.The complainant returned one rcfw-16.0p-38-30-rb unused to cook for investigation.Physical examination of the returned device showed: one sealed device received.Inspection found white foreign matter particles in the pouch.The reported failure was evident to investigators.Supplier investigation: customer could not provide a sample of the defect to oliver, therefore sample was sent to the customers lab for ftir testing.The report showed the white particles to be the adhesive applied to the tyvek.This is parent material and would not be considered foreign material.Product had been placed into the pouch prior to the adhesive particles being found.These particles found are likely due to the object inserted into the pouch scraping against the coated tyvek.A review of the device history record found no non-conformances related to the reported failure mode.A review of complaint history records shows one other complaint associated with complaint lot number 13514648.Both complaints are from the same facility.The other complaint is (b)(4) and exhibits the exact same failure with small particles found in the unopened package.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.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: "how supplied supplied sterilized by ethylene oxide gas in peel-open packages.Intended for one-time use.Sterile if package is unopened and undamaged.Do not use the product if there is doubt as to whether the product is sterile.Store in a dark, dry, cool place.Avoid extended exposure to light.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, supplier investigation and the completed investigation, cook has concluded transportation 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
• Type of Device: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 11208168
• MDR Text Key: 238664526
• Report Number: 1820334-2021-00139
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00827002116726
• UDI-Public: (01)00827002116726(17)231211(10)13514648
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 06/24/2021

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
• Device Operator: No Information
• Device Expiration Date: 12/11/2023
• Device Model Number: G11672
• Device Catalogue Number: RCFW-18.0P-38-30-RB
• Device Lot Number: 13514648
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2021
• Initial Date Manufacturer Received: 01/19/2021
• Initial Date FDA Received: 01/21/2021
• Supplement Dates Manufacturer Received: 06/18/2021
• Supplement Dates FDA Received: 06/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1