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

Model Number	G35550
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/05/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, upon completion of a fistulagram, the outer cannula/sheath included in a micropuncture transitionless stiffened cannula access set separated in the patient upon removal of the device.The access site was scarred and calcified; however, resistance was reportedly "nothing out of the ordinary".The separated portion of the device was successfully retrieved from the patient with forceps and the patient was then closed.Upon examination of the device on the back table, part of it reportedly "fell apart again".A section of the device did not remain inside the patient¿s body.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 information has been requested.
Additional Manufacturer Narrative
Device evaluated by mfg : 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.
Additional Manufacturer Narrative
Additional information: b5.Corrected information: h6 (annex e).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.
Event or Problem Description
Additional information was received 02jun2022.Nothing was placed through the complaint sheath.Sutures were used to close up the patient prior to removal of the sheath.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Summary of event: as reported, upon completion of a fistulagram, the outer cannula/sheath included in a micropuncture transitionless stiffened cannula access set separated in the patient upon removal of the device.The access site was scarred and calcified; however, resistance was reportedly "nothing out of the ordinary".Nothing was placed through the complaint sheath.The separated portion of the device was successfully retrieved from the patient with forceps and the patient was closed with sutures.Upon examination of the device on the back table, part of it reportedly "fell apart again".A section of the device did not remain inside the patient¿s body.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), 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 in two pieces.The sheath was separated 3.2 centimeters below the hub.A document-based investigation evaluation was performed.No related non-conformances were found, and there have been no other reported complaints for this lot number.The device supplier also reviewed prior non-conformances, material used, and manufacturing and quality control documents.The supplier concluded that there is no evidence that manufacturing contributed to this failure.The product ifu cautions, ¿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 scarred and calcified anatomy contributed to this event.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 has been received since the last 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: 14434935
• Report Number: 1820334-2022-00736
• Device Sequence Number: 5579642
• Product Code: DYB
• UDI-Device Identifier: 00827002355507
• UDI-Public: (01)00827002355507(17)250324(10)14621993
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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
• Report Date (Section B): 10/13/2022

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: 03/24/2025
• Device Model Number: G35550
• Device Catalogue Number: MPIS-402-10.0-SC-NT-U-SST
• Device Lot Number: 14621993
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/05/2022
• Supplement Date Received by Manufacturer: 06/02/2022; 09/27/2022
• Initial Report FDA Received Date: 05/19/2022
• Supplement Report FDA Received Date: 06/09/2022; 10/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/24/2022
• 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
• Patient Sex: Unknown