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

Model Number	G48002
Medical Device Problem Codes	Break (1069); Unraveled Material (1664)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/21/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.
Event or Problem Description
As reported, during an unknown procedure, the tip of a micropuncture transitionless stiffened cannula access set's wire separated upon removal of the device.Access was obtained in the femoral artery.The access site was not calcified or scarred, and resistance was not reported upon insertion or removal of the device.The device was not advanced through a previously-placed closure device.The wire fragment remains in the subcutaneous tissue.
Event or Problem Description
Additional information was received 17jan2023, 30jan2023, and 31jan2023.The tip of the outer sheath/cannula separated in the patient upon removal and remains in the patient¿s subcutaneous tissue.The wire guide was then damaged upon pulling the wire from the separated cannula.No part of the unraveled/separated wire remained in the patient.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Corrected information: b5, h6 (annexg)= the tip of the unraveled/separated wire guide did not remain in the patient; however, the tip of the catheter separated and remains in the subcutaneous tissue.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.
Event or Problem Description
Upon return and initial evaluation of the device, the wire was unraveled and the tip was separated.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Additional information: b5, h6 (annex a) 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.
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
Summary of event: as originally reported, during an unknown procedure, the tip of a micropuncture transitionless stiffened cannula access set's wire separated upon removal of the device.Access was obtained in the femoral artery.The access site was not calcified or scarred, and resistance was not reported upon insertion or removal of the device.The device was not advanced through a previously placed closure device.It was originally reported that the wire fragment remains in the subcutaneous tissue.Upon return and initial evaluation of the device, the wire was unraveled, and the tip was separated.Additional information was received 17jan2023, 30jan2023, and 31jan2023.The tip of the outer sheath/cannula separated in the patient upon removal and remains in the patient¿s subcutaneous tissue.The wire guide was then damaged upon pulling the wire from the separated cannula.No part of the unraveled/separated wire remained in the patient.Investigation evaluation: reviews of the complaint history, device history record, instructions for use (ifu), manufacturing instructions, and quality control procedures were conducted during the investigation.A visual inspection of the complaint device (wire guide) was also conducted.One used wire guide from the mpis set was returned for investigation.The wire was elongated just past the solder joint, and the distal end was elongated and unraveled.The tip of the wire was not present.The outer sheath/cannula was not returned to cook.A document-based investigation evaluation was performed.The device history record (dhr) for the reported lot number found no relevant non-conformances.A component lot found one relevant non-conformance; however, the non-conforming product was scrapped.A search of complaint history found no other related complaints for this lot number received from the field.The product ifu states ¿do not attempt to insert or withdraw the wire guide and/or introducer if resistance is felt¿withdrawal or manipulation of the distal spring coil portion of the mandril wire guide through a needle tip may result in breakage¿remove the dilator and the wire guide, leaving the introducer catheter in place.¿ wire or catheter embolism is listed as a potential adverse event.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.A review of relevant manufacturing and quality control documents was conducted.Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.Cook has concluded that component failure unrelated to manufacturing contributed to this event.The risk analysis for this failure mode was reviewed and no additional escalation is 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.

• 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: 15939169
• Report Number: 1820334-2022-01822
• Device Sequence Number: 20419756
• Product Code: DYB
• UDI-Device Identifier: 00827002480025
• UDI-Public: (01)00827002480025(17)250914(10)14957282
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K171275
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/17/2023

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: 09/14/2025
• Device Model Number: G48002
• Device Catalogue Number: MPIS-401-10.0-SC-SST
• Device Lot Number: 14957282
• 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: 11/21/2022
• Supplement Date Received by Manufacturer: 12/12/2022; 01/17/2023; 03/27/2023
• Initial Report FDA Received Date: 12/08/2022
• Supplement Report FDA Received Date: 01/03/2023; 02/03/2023; 04/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/14/2022
• 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: Other
• Patient Sex: Unknown