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

Model Number G02972

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/14/2022

Event Type  malfunction  

Event Description

As reported, during a subintimal arterial flossing with antegrade-retrograde intervention (safari) procedure via retrograde access in the foot, the hub of a micropuncture transitionless pedal access set's sheath separated.The lesion was reportedly difficult to cross, requiring multiple wires and catheters.Per the user, at some point during the procedure, the hub looked like it was almost detached from the sheath, so the surgeon proceeded to remove the device, at which point the hub separated completely, leaving the separated sheath in the access site.Some of the sheath was still visible and was therefore able to be removed from the patient with forceps.The device was exchanged and the procedure was continued.There have been no adverse effects to the patient.No additional procedures were required.

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.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 Description

Upon return and initial evaluation of the device, the shaft was separated inside the hub of the device.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Additional/corrected information: b5, d9, e1, e3: nurse unit manager, h6 (annex a and g) e1: (b)(6).H3: (other): the device has been returned and preliminary evaluation has been performed; however, the investigation is ongoing and the device evaluation summary will be included in a follow up report once the investigation has been completed.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.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 Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.As reported, during a subintimal arterial flossing with antegrade-retrograde intervention (safari) procedure via retrograde access in the foot, the hub of a micropuncture transitionless pedal access set's sheath separated.The lesion was reportedly difficult to cross, requiring multiple wires and catheters.Per the user, at some point during the procedure, the hub looked like it was almost detached from the sheath, so the surgeon proceeded to remove the device, at which point the hub separated completely, leaving the separated sheath in the access site.Some of the sheath was still visible and was therefore able to be removed from the patient with forceps.The device was exchanged and the procedure was continued.There have been no adverse effects to the patient.No additional procedures were required.Investigation evaluation: reviews of the complaint history, device history record, instructions for use (ifu), quality control procedures and specification were conducted during the investigation.A visual inspection of the returned complaint device was also conducted.Only the side arm of the set was returned to cook for investigation.There was part of the shaft material left in the hub.Cook's review of the device history record found no non-conformances related to the reported failure mode.A review of complaint history records shows no other related complaints associated with the complaint device lot.Because there were no related non-conformances, adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and no other lot related complaints that have been received from the field, it was concluded that there is no evidence that nonconforming product exists in house or in the field.The affected component is supplied to cook from an external supplier.The supplier's review of the lot history found no relevant non-conformances and no evidence that the manufacturing conditions contributed to this failure mode.The instructions for use (ifu) provides the following information to the user related to the reported failure mode: precautions ¿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 induce if resistance is felt.¿ how supplied ¿upon removal from 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 provides evidence the device was manufactured to specification.Based on the available information and results of the investigation, cook has concluded that component failure contributed to this failure mode.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 PEDAL ACCESS SET
• Type of Device: 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: 15184172
• MDR Text Key: 305092227
• Report Number: 1820334-2022-01318
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00827002029729
• UDI-Public: (01)00827002029729(17)250531(10)14761179
• Combination Product (y/n): N
• PMA/PMN Number: K172980
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/18/2022

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
• Device Operator: Health Professional
• Device Model Number: G02972
• Device Catalogue Number: MPIS-401-PEDAL-NT-U-SST
• Device Lot Number: 14761179
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/01/2022
• Initial Date FDA Received: 08/08/2022
• Supplement Dates Manufacturer Received: 09/01/2022; 11/14/2022
• Supplement Dates FDA Received: 09/20/2022; 11/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/31/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: COMMAND .014" WIRE.; COMMAND .018" WIRE.; CXI .018" SUPPORT CATHETER.