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

Model Number	N/A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2021
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
As reported, the tip of a performer introducer's dilator was found to be separated upon flushing the device, prior to patient contact.The device had been stored hanging in a cabinet.No damage to the device package was noted.The device was not used.
Additional Manufacturer Narrative
Description of event: as reported, the tip of a performer introducer's dilator was found to be separated upon flushing the device, prior to patient contact.The device had been stored hanging in a cabinet.No damage to the device package was noted.The device was not used.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, the instructions for use, and quality control data.The complainant returned the complaint dilator to cook for investigation.Physical examination of the returned device showed: one dilator received prior to use.The distal tip was received attached to the dilator with a piece of tape.When the tape was removed during check in, the tip fell off.The separated tip section measured 6mm, and was jagged and rough.At this time, cook concluded that the device was manufactured within specification.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: ¿supplied sterilized by ethylene oxide gas in peel-open packages.Intended for one-time use.Sterile if package is unopened or 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.Cook has concluded a component 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: 11245676
• Report Number: 1820334-2021-00193
• Device Sequence Number: 14401622
• Product Code: DYB
• UDI-Device Identifier: 00827002095823
• UDI-Public: (01)00827002095823(17)211010(10)9183995
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/22/2021

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: 10/10/2021
• Device Model Number: N/A
• Device Catalogue Number: RCFW-16.0P-38-70-RB
• Device Lot Number: 9183995
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2021
• Initial Date Received by Manufacturer: 01/14/2021
• Supplement Date Received by Manufacturer: 03/12/2021
• Initial Report FDA Received Date: 01/28/2021
• Supplement Report FDA Received Date: 03/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1