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

Model Number	G49472
Medical Device Problem Codes	Material Puncture/Hole (1504); Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/10/2022
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, during a procedure involving laser ablation, extra plastic material was noted on the outside of a micropuncture long introducer set's introducer.The user noted the material during attempted insertion of the device into the bottom of the great saphenous vein, two-to-three centimeters above the inside of the knee.The user could not confirm if the device made patient contact.The device was removed from the field and another device of the same type was used to successfully complete the procedure.
Additional Manufacturer Narrative
(b)(6).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
H3: device evaluated by mfg = other (81) - 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.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
Upon return and initial evaluation of the device on 08jul2022, the shaft material appeared to be punctured and the material around the puncture was pulled and elongated.Information was available but inadvertently omitted from the previous report: a section of the device did not remain inside the patient's body.The patient did not require any additional procedures due to the occurrence.According to the initial reporter, the patient did not experience any adverse effects.
Event or Problem Description
No additional information has been received since the last report was submitted.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Summary of event: as reported, during a procedure involving laser ablation, extra plastic material was noted on the outside of a micropuncture long introducer set's introducer.The user noted the material during attempted insertion of the device into the bottom of the great saphenous vein, two-to-three centimeters above the inside of the knee.The user could not confirm if the device made patient contact.The device was removed from the field and another device of the same type was used to successfully complete the procedure.A section of the device did not remain inside the patient's body.The patient did not require any additional procedures due to the occurrence.According to the initial reporter, the patient did not experience any adverse effects.Upon return and initial evaluation of the device on (b)(6) 2022, the shaft material appeared to be punctured and the material around the puncture was pulled and elongated.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 complaint device was also conducted.The inner and outer catheters of the complaint device were returned to cook for investigation.Shaft damage was noted at approximately 20-centimeters from the hub on the outer catheter.The shaft appeared to have been punctured, and the material around the puncture was pulled and elongated.Physical examination confirmed that the device was built out of specification.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 product ifu states ¿upon removal from the package, inspect the product to ensure no damage has occurred.¿ 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 out of specification; however, as there were no related non-conformances or additional complaints on the lot, there is no evidence of additional 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 a quality control deficiency contributed to this incident.Responsible personnel were notified.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.

• Brand Name: MICROPUNCTURE LONG INTRODUCER 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: 14859235
• Report Number: 1820334-2022-01130
• Device Sequence Number: 4793394
• Product Code: DYB
• UDI-Device Identifier: 00827002494725
• UDI-Public: (01)00827002494725(17)250215(10)14539053
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 10/25/2022

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: 02/15/2025
• Device Model Number: G49472
• Device Catalogue Number: MPIS-5017-18-30.0-LEH
• Device Lot Number: 14539053
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/13/2022
• Supplement Date Received by Manufacturer: 07/08/2022; 09/28/2022
• Initial Report FDA Received Date: 06/29/2022
• Supplement Report FDA Received Date: 07/13/2022; 10/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/15/2022
• 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
• Patient Sex: Unknown