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

Model Number	G35550
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	08/26/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pma/510(k) number: k171275.(b)(4).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 via medwatch #5089425, during an unknown procedure involving a patient of unknown age and gender, a micropuncture traditionless stiffened cannula access set sheath sheared off in the right groin.Access was obtained in the right common femoral artery.As the sheath was exchanged, approximately five centimeters of the distal portion of the micropuncture sheath sheared off upon removal of the device.Reportedly, the patient was hospitalized as a result of the event.Additional information regarding event details, patient anatomy and outcome has been requested, but is not available at this time.
Additional Manufacturer Narrative
Event summary: as reported via medwatch#5089425, during an unknown procedure involving a patient of unknown age and gender, a micropuncture transitionless stiffened cannula access set sheath sheared off in the right groin.Access was obtained in the right common femoral artery.As the sheath was exchanged, approximately five centimeters of the distal portion of the micropuncture sheath sheared off upon removal of the device.Reportedly, the patient was hospitalized as a result of the event.Investigation/evaluation: reviews of the complaint history, device history record, drawing, manufacturing instructions, quality control procedures, 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 conducted.A review of the device history record shows no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.The affected device component is provided by a supplier.The supplier reviewed the manufacturing records for this lot and concluded that there were not any documented anomalies or non-conformances regarding the manufacturing process for the identified lots.Reviews of quality control procedures, manufacturing instructions, specifications, and drawings were also conducted, and no gaps were discovered.The available information provides objective evidence to support that the device was manufactured to specification.Based on the information provided, investigation has concluded that a cause for the device failure could not 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.
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: 9135390
• Report Number: 1820334-2019-02455
• Device Sequence Number: 14090132
• Product Code: DYB
• UDI-Device Identifier: 00827002355507
• UDI-Public: (01)00827002355507(17)220607(10)9796873
• 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,other
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 04/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/07/2022
• Device Model Number: G35550
• Device Catalogue Number: MPIS-402-10.0-SC-NT-U-SST
• Device Lot Number: 9796873
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/16/2019
• Supplement Date Received by Manufacturer: 03/25/2020
• Initial Report FDA Received Date: 09/30/2019
• Supplement Report FDA Received Date: 04/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization