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

Model Number	G08024
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/29/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Occupation: unknown.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
It was reported that the connector on top of a performer introducer was found to be loose upon opening the package.The device did not make patient contact.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
Investigation - evaluation a review of the complaint history, drawings, device history record, documentation, instructions for use (ifu), manufacturing instructions, specifications, quality control, and visual inspection of the returned device was conducted during the investigation.One performer introducer sheath, a wire guide, and three dilators (sizes 10fr, 12fr, and 14fr) were returned for investigation.The product does not appear used, as there is no biomatter.There is no noted damage to the sheath, wire guide, or the 10fr or the 12fr dilator.However, the hub of the 14fr dilator was separated from the shaft.The separation appears clean as if it were cut or sliced.The dilator does not appear to have been folded, bent, or experienced any forces that would cause separation.There are a few kinks on the sheath, but these appear unrelated.Additionally, a document-based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.A review of the device history record for the reported lot and subassembly lots showed no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.Furthermore, reviews of the manufactures instructions and quality control procedures were conducted, and no gaps were discovered.The instructions for use (ifu) provided with the device states: ¿how supplied - ¿.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¿.The customer report of the hub of the dilator separating from the shaft has been confirmed based on visual examination of the returned device; however, based on the information provided and the examination of the returned product, investigation has concluded the cause of this event cannot be established.We will continue our monitoring of similar complaints and have notified the appropriate personnel of this event.Per the quality engineering risk assessment, no further action is required.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.

• Brand Name: PERFORMER INTRODUCER
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8326018
• Report Number: 1820334-2019-00334
• Device Sequence Number: 18883468
• Product Code: DYB
• UDI-Device Identifier: 00827002080249
• UDI-Public: (01)00827002080249(17)211116(10)9271840
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/12/2019

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: 11/16/2021
• Device Model Number: G08024
• Device Catalogue Number: RCF-14.0-38-J
• Device Lot Number: 9271840
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2019
• Initial Date Received by Manufacturer: 01/30/2019
• Supplement Date Received by Manufacturer: 04/11/2019
• Initial Report FDA Received Date: 02/11/2019
• Supplement Report FDA Received Date: 04/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1