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

Model Number	G48004
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/30/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Initial reporter occupation: rt.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, during a transjugular liver biopsy procedure, a micropuncture transitionless stiffened cannula access set's outer sheath separated upon insertion of the device.Access was obtained in the internal jugular vein and the access site was reportedly extremely scarred.Advancement of the introducer was extremely difficult.The resistance encountered necessitated the use of multiple cook dilators, up to 8 french, to dilate the access site.The outer cannula/sheath separated and subsequently migrated to the right side of the patient's heart.The user attempted to retrieve the separated portion of the device two times with a snare; however, this was unsuccessful, and the distal piece of the device remains lodged in the heart.The patient is reportedly asymptomatic.There have been no adverse effects due to this event.
Event or Problem Description
Additional information was received 30jul2022.The sheath fragment was successfully retrieved from the patient and sent to pathology on (b)(6) 2022.There have been no other reported adverse effects to the patient, who is reportedly doing well.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.H3: device evaluated by mfg = other (81) - 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.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.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Summary of event: as reported, during a transjugular liver biopsy procedure, a micropuncture transitionless stiffened cannula access set's outer sheath separated upon insertion of the device.Access was obtained in the internal jugular vein and the access site was reportedly extremely scarred.Advancement of the introducer was extremely difficult.The resistance encountered necessitated the use of multiple cook dilators, up to 8 french, to dilate the access site.The outer cannula/sheath separated and subsequently migrated to the right side of the patient's heart.The user attempted to retrieve the separated portion of the device two times with a snare; however, this was unsuccessful, and the distal piece of the device remained lodged in the heart.The patient was reportedly asymptomatic.Additional information was received (b)(6) 2022.The sheath fragment was successfully retrieved from the patient and sent to pathology on (b)(6) 2022.There have been no other reported adverse effects to the patient, who was reportedly doing well.Investigation evaluation: reviews of the complaint history, device history record, instructions for use (ifu), and quality control procedures were conducted during the investigation.A visual inspection of the complaint device was also conducted.The complaint device was returned for investigation.The outer catheter was separated approximately two centimeters from the hub.A document-based investigation evaluation was performed.There have been no other reported complaints for this lot number.One relevant non-conformance was noted on a subassembly lot; however, all affected product was scrapped, there are 100% inspections in place to capture the non-conformance, and there is objective evidence that the dhr was fully executed.The product ifu states ¿do not attempt to insert or withdraw the wire guide and/or introducer if resistance is felt¿.The information provided upon review of the dmr, dhr, ifu, and investigation of the returned device suggests that there is evidence the device was manufactured to specification.There is no evidence of non-conforming devices in-house or in the field.Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.Based on the information provided and the results of the investigation, cook has concluded that the patient¿s anatomy contributed to this event, as the access site was extremely scarred, and resistance was encountered during insertion.The risk analysis for this failure mode was reviewed and no additional escalation was required.The appropriate personnel have been notified and cook will continue to monitor for similar events.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 or event has been received since the last medwatch report was submitted.

• 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
• Manufacturer (Section G): COOK INC.; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 15085442
• Report Number: 1820334-2022-01258
• Device Sequence Number: 17387068
• Product Code: DYB
• UDI-Device Identifier: 00827002480049
• UDI-Public: (01)00827002480049(17)250525(10)14752293
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K171275
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/17/2022

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: 05/25/2025
• Device Model Number: G48004
• Device Catalogue Number: MPIS-401-10.0-SC-NT-U-SST
• Device Lot Number: 14752293
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/08/2022
• Supplement Date Received by Manufacturer: 07/30/2022; 10/28/2022
• Initial Report FDA Received Date: 07/22/2022
• Supplement Report FDA Received Date: 08/03/2022; 11/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/25/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown