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

Catalog Number	MPIS-501-SST
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, during a right heart catheterization via access in the right internal jugular vein, a micropuncture transitionless access set's wire unraveled.Access was obtained using ultrasound guidance and the puncture was described as uneventful.The wire got stuck within the access needle, and was unable to be advanced or retrieved.The user removed the access needle; however, the wire remained in the right internal jugular vein, with the tip stretching out "like a thread".A vascular surgeon was called and an open retrieval was performed.Additional information has been requested.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.D9, h3: it is unknown if the device will be returned.E1: customer name and address = postal: (b)(6).E3: occupation = "cn".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 received 20jun2024 stating the access site was normal and not scarred.Venous blood aspirated freely before wire guide advancement.Resistance was felt during insertion of the wire and also felt while attempting to remove the guide wire while pulling the guide wire backwards.An attempt to pull the entire wire back with the access needle was made; however, just the needle was removed."gentle traction" was used to pull the wire out, and the "soft part" unraveled but was in one piece.Fluoroscopy guided dissection easily identified the tip of wire.The wire was entering the vein on the lateral wall.There was no other abnormality detected.The patient's recovery was described as "uneventful' following the surgical wire retrieval.The following day, the patient underwent a femoral approach right heart catheter procedure and was discharged that same day.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable or unchanged.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.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
Additional Manufacturer Narrative
Summary of event: as reported, during a right heart catheterization via access in the right internal jugular vein, a micropuncture traditionless access set's wire unraveled.Access was obtained using ultrasound guidance and the puncture was described as uneventful.The wire got stuck within the access needle and was unable to be advanced or retrieved.The user removed the access needle; however, the wire remained in the right internal jugular vein, with the tip stretching out "like a thread".A vascular surgeon was called, and an open retrieval was performed.Additional information received 20jun2024 stating the access site was normal and not scarred.Venous blood aspirated freely before wire guide advancement.Resistance was felt during insertion of the wire and felt while attempting to remove the guide wire while pulling the guide wire backwards.An attempt to pull the entire wire back with the access needle was made; however, just the needle was removed."gentle traction" was used to pull the wire out, and the "soft part" unraveled but was in one piece.Fluoroscopy guided dissection easily identified the tip of wire.The wire was entering the vein on the lateral wall.There was no other abnormality detected.The patient's recovery was described as "uneventful' following the surgical wire retrieval.The following day, the patient underwent a femoral approach right heart catheter procedure and was discharged that same day.Investigation evaluation: reviews of the complaint history, device history record (dhr), 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.A review of the device history record found no relevant non-conformance's on the lot.One relevant non-conformance, involving three devices, was noted on a component lot; however, all non-conforming product was scrapped prior to release.A review of complaint history found one additional relevant complaint for this lot number.The ifu states "caution: 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.¿ a review of the device master record (dmr) concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.The information provided upon review of the dmr, dhr, and ifu suggests that there is evidence the device was manufactured to specification.Although one relevant non-conformance was noted on a component lot, all non-conforming product was scrapped, there are 100% inspections in place to capture this non-conformance, adequate inspection activities have been established, and there is objective evidence that the dhr was fully executed.Therefore, it was concluded that there is no evidence that additional non-conforming product exists in-house or in the field.Based on the information provided and the results of the investigation, cook has concluded that failure to follow instructions contributed to this event.The user felt resistance when advancing the wire as well as while pulling the wire backward.Despite the attempt to remove the wire guide and access needle simultaneously, as directed in the ifu, the wire had been previously manipulated backwards through the access needle, most likely causing the wire to break.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 and/or event has been received since the previous medwatch report was sent.

• 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: 19154761
• Report Number: 1820334-2024-00562
• Device Sequence Number: 20792062
• Product Code: DYB
• UDI-Device Identifier: 00827002363335
• UDI-Public: (01)00827002363335(17)261110(10)15751013
• Combination Product (Y/N): N
• PMA/510(K) Number: K171275
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/17/2024

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 Catalogue Number: MPIS-501-SST
• Device Lot Number: 15751013
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/01/2024
• Supplement Date Received by Manufacturer: 06/20/2024; 06/28/2024
• Initial Report FDA Received Date: 04/22/2024
• Supplement Report FDA Received Date: 06/27/2024; 07/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/10/2023
• 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
• Patient Sex: Unknown