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

Model Number	G48007
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/05/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Occupation- risk manager.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 via a medwatch report, while obtaining vascular access during an unspecified procedure, the tip of a wire included in a micropuncture transitionless stiffened cannula access set separated in the right common femoral artery.No access was obtained on the right side.A cardiovascular surgeon was called to perform a selective cannulation of the right proximal external iliac artery from a left femoral approach.A snare was used to remove "the entire system" and constant pressure was maintained.The procedure was completed with no further complications.Additional information has been requested, but is not available at this time.
Additional Manufacturer Narrative
Event summary: as reported via a medwatch report, while obtaining vascular access during a percutaneous coronary intervention, the tip of a wire included in a micropuncture transitionless stiffened cannula access set separated in the right common femoral artery.No access was obtained on the right side.A cardiovascular surgeon was called to perform a selective cannulation of the right proximal external iliac artery from a left femoral approach.A snare was used to remove "the entire system" and constant pressure was maintained.The procedure was completed with no further complications.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, drawing, manufacturing, and quality control procedures of the device were conducted during the investigation.No device was returned for investigation.A document-based investigation evaluation was performed.Two relevant non-conformances were recorded; all non-conforming product was scrapped and there are 100% inspections in place to capture this non-conformance.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.A review of relevant manufacturing documents was conducted.No gaps in production or processing controls were noted.There is no indication that a design or process related failure mode contributed to the reported event.Review of production and quality documentation did not observe any specific issues with current manufacturing or quality controls that may have contributed to this incident.The device is provided with instructions for use which caution, ¿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.Withdrawal or manipulation of the distal spring coil portion of the mandril wire guide through a needle tip may result in breakage.¿ based on the available information, cook has concluded that a component failure unrelated to manufacturing or design deficiencies contributed to this incident.Cook will continue monitoring of similar complaints and has notified the appropriate personnel of this event.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.
Event or Problem Description
Hold for cr 10.18 no additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
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 was received on 29jun2021.The procedure performed was a percutaneous coronary intervention.The patient did not experience any adverse effects due to this occurrence.

• 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
• MDR Report Key: 11777105
• Report Number: 1820334-2021-01289
• Device Sequence Number: 3550124
• Product Code: DYB
• UDI-Device Identifier: 00827002480070
• UDI-Public: (01)00827002480070(17)240110(10)13678689
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: company representative,health
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/29/2021

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: 01/10/2024
• Device Model Number: G48007
• Device Catalogue Number: MPIS-501-10.0-SC-NT-SST
• Device Lot Number: 13678689
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/20/2021
• Supplement Date Received by Manufacturer: 06/29/2021; 09/21/2021
• Initial Report FDA Received Date: 05/05/2021
• Supplement Report FDA Received Date: 07/20/2021; 09/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ENSNARE.; ENSNARE
• Outcome Attributed to Adverse Event: Required Intervention