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

Model Number	G48002
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/08/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Occupation: non-healthcare professional.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, the metal in the micropuncture transitionless stiffened cannula access set's inner cannula separated at the beginning of a deep vein thrombosis (dvt) lysis procedure.Access was obtained in the right popliteal.The user did not experience resistance and the patient did not require additional procedures as a result of the event.The procedure was completed successfully with an "angio d" set.The female patient, age unspecified, has pain at the site, but it isn't certain the pain is related to the complaint device.It was reported a portion of the device was not retained in the patient's anatomy.
Additional Manufacturer Narrative
A review of the complaint history, device history record, documentation, drawing, manufacturing instructions, quality control, and a visual inspection of the returned device were conducted during the investigation.The visual inspection of the returned device confirmed that the cannula of the inner shaft was completely separated from the hub.The outer sheath was slightly curved but otherwise undamaged.The inner shaft was curved at the end, with indentations along the curvature up to and including the distal tip.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 showed no nonconforming events which could contribute to this failure mode.It should be noted there has been one other complaint associated with this lot number, however the complaint is unrelated and not associated with this failure mode.Furthermore, the micropuncture coaxial catheters are purchased from an approved vendor.The follow investigation was received from that supplier "a review of the manufacturing data on [the lots provided] did not reveal any obvious manufacturing anomalies.All process parameters were within validation ranges and all inspection requirements were satisfied.The manufacturing process for this product requires the cannula to be stuffed into the tube and the assembly inserted into the injection mold for the hubbing process.The defect depicted in the photos indicates that the cannula was not properly loaded into the injection mold.It is probable that the unflared end of the cannula was inserted into the mold resulting in poor retention.The event will be communicated to the department and we will investigate alternate detection methods to prevent recurrence." moreover, a review of cook's manufacturer's instructions and quality control procedures was conducted, and no gaps were discovered.There is no additional labeling addressing this failure mode.Based on the information provided, the examination of the returned product, and the results of our investigation, the cause of this event can be traced to manufacturing and supplier manufacturing deficiency.As supplier manufacturing deficiency is not properly represented in the fda codes, code 4316 was selected.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.
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: 8336776
• Report Number: 1820334-2019-00421
• Device Sequence Number: 2357591
• Product Code: DYB
• UDI-Device Identifier: 00827002480025
• UDI-Public: (01)00827002480025(17)211113(10)9309180
• 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): 04/26/2019

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: 11/13/2021
• Device Model Number: G48002
• Device Catalogue Number: MPIS-401-10.0-SC-SST
• Device Lot Number: 9309180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2019
• Initial Date Received by Manufacturer: 02/08/2019
• Supplement Date Received by Manufacturer: 04/24/2019
• Initial Report FDA Received Date: 02/13/2019
• Supplement Report FDA Received Date: 04/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1