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

Model Number	G47949
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/15/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, during a femoral angiogram, the wire included in a micropuncture transitional access set separated.The patient was described as "large" and access was difficult.The wire was passed through the entry needle three times prior to separating in the patient.An image provided by the customer shows a wire fragment within the groin, above the femoral head.The patient was then placed under general anesthesia, and an open procedure involving a femoral cut-down was performed to successfully retrieve the separated portion of the wire.The patient is reportedly doing well.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.Customer name and address= mobile phone: (b)(6).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
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 reported, during a femoral angiogram, the wire included in a micropuncture transitionless access set separated.The patient was described as "large" and access was difficult.The wire was passed through the entry needle three times prior to separating in the patient.An image provided by the customer shows a wire fragment within the groin, above the femoral head.The patient was then placed under general anesthesia, and an open procedure involving a femoral cut-down was performed to successfully retrieve the separated portion of the wire.The patient is reportedly doing well.Investigation evaluation: reviews of the complaint history, device history record, instructions for use (ifu), and quality control procedures were conducted during the investigation.A visual inspection of the returned complaint device was also conducted.The complaint device was returned in a used and damaged condition.The coil was elongated, having a length measurement of approx.7.5cm.The distal weld ball was also missing.Cook completed a review of the device history record (dhr).The dhr for the reported lot found no related non-conformances.A wire guide component lot associated with the complaint lot found on relevant non-conformance on 16 devices for broken wire, however, the devices were scrapped.Although these non-conformances are relevant to the reported failure mode, all non-conforming product was scrapped, there are 100% inspections to capture this non-conformance, adequate inspection activities have been established, and there are no other lot related complaints that have been received from the field.At this time, cook concluded that no non-conforming product from this lot exists in house or in the field.A document review was completed as a response to this event.A device master record (dmr) review was performed, and the device quality control procedures associated with the complaint were identified.Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.The instructions for use (ifu) provides the following information to the user related to the reported failure mode: precautions ¿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.¿ cook has concluded that unintended user error is the cause for this failure as it was stated that ¿the wire was passed 3 times¿ through the entry needle.The ifu warns: ¿withdrawal or manipulation of the distal spring coil portion of the mandril wire guide through a needle tip may result in breakage.¿ the appropriate personnel have been notified and cook will continue to monitor for similar events.Per the quality engineering risk assessment, no further action is required.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: 13904978
• Report Number: 1820334-2022-00459
• Device Sequence Number: 4065301
• Product Code: DYB
• UDI-Device Identifier: 00827002479494
• UDI-Public: (01)00827002479494(17)241021(10)14299033
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/26/2022

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: 10/21/2024
• Device Model Number: G47949
• Device Catalogue Number: MPIS-401-U-SST
• Device Lot Number: 14299033
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/15/2022
• Supplement Date Received by Manufacturer: 05/25/2022
• Initial Report FDA Received Date: 03/25/2022
• Supplement Report FDA Received Date: 05/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/21/2021
• 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: Male