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

Model Number	G36333
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/01/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Occupation: cath lab coordinator.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 procedure involving placement of a port, the wire included in a micropuncture transitionless access set separated in the patient upon insertion.Access was obtained in the right internal jugular vein.The wire would not advance as the user attempted to place it through the needle, and it was reportedly noted that the wire was not in the vein.Resistance was encountered upon removal of the wire, which reportedly separated, leaving a fragment of the wire in the patient.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Additional information: b5, h6 (annex f) h6 (annex f): a portion of the wire remains in the patient's neck.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
Additional information was received 26apr2022.Needle placement was confirmed upon needle insertion, via ultrasound and blood return.The needle was in place during several attempts to remove the wire.The needle was then removed, and several additional attempts were made to remove the wire guide.A fragment of the wire remains in the patient¿s neck.
Event or Problem Description
No additional information has been received since the last report was submitted.
Additional Manufacturer Narrative
Summary of event: as reported, during a procedure involving placement of a port, the wire included in a micropuncture transitionless access set separated in the patient upon insertion.Access was obtained in the right internal jugular vein.Needle placement was confirmed upon needle insertion, via ultrasound and blood return.The wire would not advance as the user attempted to place it through the needle, and it was reportedly noted that the wire was not in the vein.Resistance was encountered upon removal of the wire, which reportedly separated, leaving a fragment of the wire in the patient¿s neck.The needle was in place during several attempts to remove the wire.The needle was then removed, and several additional attempts were made to remove the wire guide.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Investigation evaluation: reviews of the complaint history, device history record, instructions for use (ifu), and quality control procedures were conducted during the investigation.The complaint device was not returned to cook for investigation.A document-based investigation evaluation was performed.There have been no other reported complaints for this lot number.One related nonconformance was noted on a subassembly lot; however, the affected product was scrapped and there are 100% inspections in place for this nonconformance.The product ifu cautions, ¿do not attempt to insert or withdraw the wire guide and/or introducer if resistance is felt¿; and ¿withdrawal or manipulation of the distal spring coil portion of the mandril wire guide through a needle tip may result in breakage¿.The ifu instructs the use, ¿do not withdraw the wire guide through the introducer needle; breakage may result.If the wire guide tip must be withdrawn while the needle is inserted, remove both the needle and the wire as a unit.¿ the information provided upon review of the dmr, dhr, and ifu 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 unintended user error contributed to this event, as the needle was in place during several attempts to remove the wire guide.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.

• Brand Name: MICROPUNCTURE TRANSITIONLESS 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: 14163595
• Report Number: 1820334-2022-00624
• Device Sequence Number: 5755251
• Product Code: DYB
• UDI-Device Identifier: 00827002363335
• UDI-Public: (01)00827002363335(17)250308(10)14585804
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/30/2022

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: 03/08/2025
• Device Model Number: G36333
• Device Catalogue Number: MPIS-501-SST
• Device Lot Number: 14585804
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/01/2022
• Supplement Date Received by Manufacturer: 04/26/2022; 06/20/2022
• Initial Report FDA Received Date: 04/20/2022
• Supplement Report FDA Received Date: 05/10/2022; 06/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/08/2022
• 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: Female