MAUDE Adverse Event Report: COOK INC MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET; DYB INTRODUCER, CATHETER

Model Number	G35550
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, or unavailable.Occupation: non-healthcare professional.Pma/510(k) number: k171275.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, a micropuncture transitionless stiffened cannula access set introducer was frayed prior to patient use.The complaint device did not make patient contact and no additional procedures were necessary.A new cook micropuncture set was opened and used to complete the procedure.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.H3: the device was not returned for investigation.Investigation - evaluation.Reviews of the complaint history, device history record, manufacturer¿s instructions, quality control procedures, instructions for use (ifu), documentation, and specifications of the device were conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, 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 shows a single possibly related nonconforming event, but the affected unit was scrapped and not replaced.It should be noted there were no other reported complaints for this lot number.Furthermore, reviews of the manufacturer¿s instructions, specifications, documentation, and quality control procedures were conducted, and no gaps were discovered.This product is supplied with instructions for use, which instructs the user ¿upon removal from the package, inspect the product to ensure no damage has occurred¿.Based on the information provided and no product returned, investigation has concluded that the most likely cause for the device failure was inadvertent handling damage sustained during shipping or transport.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.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.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8707907
• Report Number: 1820334-2019-01469
• Device Sequence Number: 19330873
• Product Code: DYB
• UDI-Device Identifier: 00827002355507
• UDI-Public: (01)00827002355507(17)220208(10)9509996
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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): 09/16/2019

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: 02/08/2022
• Device Model Number: G35550
• Device Catalogue Number: MPIS-402-10.0-SC-NT-U-SST
• Device Lot Number: 9509996
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/12/2019
• Supplement Date Received by Manufacturer: 09/13/2019
• Initial Report FDA Received Date: 06/18/2019
• Supplement Report FDA Received Date: 09/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1