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

Model Number	G47940
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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, the end of an unspecified component of a micropuncture transitionless access set separated during advancement into the patient.The separated fragment was able to be retrieved, and the procedure was completed.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.The patient did not experience any adverse effects due to this occurrence.Additional event information has been requested.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Description of event: as reported, the end of an unspecified component of a micropuncture transitionless access set separated during advancement into the patient.The separated fragment was able to be retrieved, and the procedure was completed.Investigation ¿ evaluation: a visual inspection of the returned device was conducted.A document based investigation was also performed including a review of complaint history, device history record, the instructions for use, manufacturing instructions, and quality control data.The complainant returned one mpis-401-sst set without the 21 gauge needle was returned.The supplied outer 4.0fr catheter was returned in a used and damaged condition.Separation was present with one section measuring 2.9cm and the other approximately 7.6cm.Material elongation was present at both points of separation.The distal tip was damaged.There is no evidence from device failure analysis that the complaint was manufactured out of specification.A review of the device history record (dhr) found two non-conformances relevant to the reported failure mode; all affected devices were scrapped, and there are 100% inspections to capture both non-conformances.There have been no other reported complaints for this lot number.The device history record review provides objective evidence that the device was manufactured to specification.There is no evidence of nonconforming devices from the complaint lot in house or in the field.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: ¿when inserting, manipulating or withdrawing a device through an introducer, always maintain introducer position.¿do not attempt to insert or withdraw the wire guide and/or introducer if resistance is felt.A review of relevant manufacturing documents was conducted.It was concluded that the device aspect in question was visually/functionally inspected by quality control, and no related gaps in production or processing controls were noted.Based on the available information, cook has concluded that shipping/handling contributed to this incident.Per the quality engineering risk assessment, no further action is warranted.Cook will continue to monitor this device via the complaints database for similar complaints.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
No new patient or event information to report.

• 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: 11999209
• Report Number: 1820334-2021-01509
• Device Sequence Number: 17041365
• Product Code: DYB
• UDI-Device Identifier: 00827002479401
• UDI-Public: (01)00827002479401(17)240220(10)13771832
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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
• Report Date (Section B): 11/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/20/2024
• Device Model Number: G47940
• Device Catalogue Number: MPIS-401-SST
• Device Lot Number: 13771832
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/01/2021
• Supplement Date Received by Manufacturer: 10/27/2021
• Initial Report FDA Received Date: 06/15/2021
• Supplement Report FDA Received Date: 11/15/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/20/2021
• 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
• Patient Sex: Unknown