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

Model Number	G48003
Medical Device Problem Codes	Break (1069); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Foreign Body Embolism (4439)
Date of Event	10/30/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
E1: name and address = phone: (b)(6).G4: pma/510(k) number = k240589.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 a fistulagram, a micropuncture transitionless stiffened cannula access set¿s sheath was inadvertently/accidentally transected/cut by the user.Per the reporter, the fistula had been extensively stented at another facility, except for approximately one centimeter of the mid-fistula, which is where access was obtained for the fistulagram.The fistulagram showed narrowing of the stents.The patient had severe ulnar disease, and the main flow to the hand was the radial artery.Severe ¿steal¿ was noted due to the fistula.Reportedly, there was no option for plication, as the fistula was extensively stented, and patency of the fistula was also poor due to the extent of stenting.Therefore, the user decided to ligate the fistula.Per the reporter, the only area to ligate was within the same area as the access site, where the complaint device was located.During dissection of the tissues, bleeding was reported.As the user dissected to gain control of the bleeding, the sheath was inadvertently transected.The user was unable to locate the distal tip of the sheath.An ultrasound of the arm was performed, as well as intravenous ultrasound, transesophageal echocardiogram, and pulmonary arteriogram; however, the fragment was not located.The next day, the patient developed a pulmonary artery embolism due to the foreign body.An interventional pulmonary arteriogram was performed, finding the sheath fragment in the left lower lung.The fragment was unable to be retrieved with a suction thrombectomy catheter; however, a snare was used to successfully remove the fragment in its entirety.Per the reporter, the physician does not feel that there was anything wrong with the device, as it was accidentally cut during the procedure.
Event or Problem Description
Additional information was received 11dec2024.The ligation was completed successfully.Per the reporter, there was no concern with device functionality.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Additional information: b5.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
Summary of event: as reported, during a fistulogram, a micropuncture traditionless stiffened cannula access set¿s sheath was inadvertently/accidentally transected/cut by the user.Per the reporter, the fistula had been extensively stented at another facility, except for approximately one centimeter of the mid-fistula, which is where access was obtained for the fistulogram.The fistulogram showed narrowing of the stents.The patient had severe ulnar disease, and the main flow to the hand was the radial artery.Severe ¿steal¿ was noted due to the fistula.Reportedly, there was no option for plication, as the fistula was extensively stented, and patency of the fistula was also poor due to the extent of stenting.Therefore, the user decided to ligate the fistula.Per the reporter, the only area to ligate was within the same area as the access site, where the complaint device was located.During dissection of the tissues, bleeding was reported.As the user dissected to gain control of the bleeding, the sheath was inadvertently transected.The user was unable to locate the distal tip of the sheath.An ultrasound of the arm was performed, as well as intravenous ultrasound, transesophageal echocardiogram, and pulmonary arteriogram; however, the fragment was not located.The next day, the patient developed a pulmonary artery embolism due to the foreign body.An interventional pulmonary arteriogram was performed, finding the sheath fragment in the left lower lung.The fragment was unable to be retrieved with a suction thrombectomy catheter; however, a snare was used to successfully remove the fragment in its entirety.Per the reporter, the physician does not feel that there was anything wrong with the device, as it was accidentally cut during the procedure.Additional information was received 11dec2024.The ligation was completed successfully.Per the reporter, there was no concern with device functionality.Corrected information: h6 (annex a).Investigation evaluation: reviews of the complaint history, device history record (dhr), instructions for use (ifu), manufacturing instructions, and quality control procedures were conducted during the investigation.A visual inspection of the complaint device was also conducted.The complaint device was returned to cook for investigation.The outer catheter had been cut approximately 3.8-centimeters from the hub.The distal portion of the catheter measured approximately 5.5-centimeters in length.The distal tip was bunched and out of round.A document-based investigation evaluation was performed.A review of the device history record found no relevant non-conformances on the lot.A review of complaint history found no additional complaints for this lot number.A review of the device master record (dmr) concluded that sufficient inspection activities are in place prior to distribution.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.Based on the information provided and the results of the investigation, cook has concluded that procedural issues contributed to this event.During ligation of the fistula and dissection of tissues in the same one-centimeter area as the sheath/outer catheter, the device was accidentally cut by the user during attempts to control bleeding.The risk analysis 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 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: 20866639
• Report Number: 1820334-2024-01608
• Device Sequence Number: 18298298
• Product Code: DYB
• UDI-Device Identifier: 00827002480032
• UDI-Public: (01)00827002480032(17)270805(10)16190505
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/09/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: G48003
• Device Catalogue Number: MPIS-401-10.0-SC-NT-SST
• Device Lot Number: 16190505
• 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: 11/15/2024
• Supplement Date Received by Manufacturer: 12/11/2024; 04/15/2025
• Initial Report FDA Received Date: 12/06/2024
• Supplement Report FDA Received Date: 12/17/2024; 05/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/05/2024
• 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; Required Intervention
• Patient Age: 53 YR
• Patient Sex: Female
• Patient Weight: 126 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American