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

Model Number	G47709
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/24/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, or unavailable.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
It was reported, during an unspecified procedure involving the micropuncture traditionless pediatric access set, the wire guide separated.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 regarding event details, patient anatomy and outcome has been requested, but is not available at this time.
Additional Manufacturer Narrative
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
Additional information received 08sep2020.This event occurred during treatment of a patent ductus arteriosus.
Additional Manufacturer Narrative
Summary of event: it was reported, during an unspecified procedure involving the micropuncture transitionless pediatric access set, the wire guide separated.Additional information received 08sep2020.This event occurred during treatment of a patent ductus arteriosus.Additional information received 15jan2021.The user found that the wire guide separated when it was moved to the surgical table.The access site was not scarred.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.The complaint device was not returned to cook for investigation.The device master record (dmr) was reviewed and device manufacturing instructions and quality control procedures were identified.Sufficient controls are in place to detect this failure mode prior to release.The device instructions for use (ifu) lists steps relevant to this failure mode.A review of the device history record (dhr) showed one related nonconformance, but all nonconforming product was scrapped, and quality control procedures were performed on all devices in the lot.A database search revealed no other complaints under this lot number at the time of this investigation.The product¿s design history file (dhf) shows evidence of verifications in place to meet design requirements related to this failure mode.The information provided upon review of the dmr, ifu, dhr, and dhf suggests that the device was manufactured within specification.There is no evidence of nonconforming devices in house or out in the field.Based on the information provided and the results of the investigation, cook has concluded that component failure unrelated to manufacturing or design deficiencies contributed to the failure mode.It is possible that the user inadvertently manipulated the wire guide with excessive force, resulting in the unspecified damage.However, this cannot be confirmed without photos or additional information.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
Additional information received 15jan2021.The user found that the wire guide separated when it was moved to the surgical table.The access site was not scarred.

• Brand Name: MICROPUNCTURE TRANSITIONLESS PEDIATRIC ACCESS SET
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 10504438
• Report Number: 1820334-2020-01646
• Device Sequence Number: 3155231
• Product Code: DYB
• UDI-Device Identifier: 00827002477094
• UDI-Public: (01)00827002477094(17)220903(10)9987710
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K171275
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/27/2021

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: 09/03/2022
• Device Model Number: G47709
• Device Catalogue Number: MPIS-501-PED-SST
• Device Lot Number: 9987710
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/02/2020
• Supplement Date Received by Manufacturer: 09/08/2020; 01/15/2021
• Initial Report FDA Received Date: 09/08/2020
• Supplement Report FDA Received Date: 10/01/2020; 01/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1