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

Model Number G48003

Device Problem Material Split, Cut or Torn (4008)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/12/2021

Event Type  malfunction  

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 Description

As reported, during an arteriogram of the lower leg via femoral access, a micropuncture transitionless stiffened cannula access set's coaxial system split.The user was able to insert the needle and wire guide into the heavily calcified and scarred groin; however, upon insertion of the coaxial system, both the inner and outer cannulas bent and broke, splitting longitudinally.Resistance was reported upon both insertion and removal of the device.The wire was still in place and the entire complaint device was removed over the wire, abandoning the access site.Another device of the same type was used to access an alternate site and the procedure was completed successfully.Although the patient had undergone multiple previous procedures via groin access, a closure device was not in place.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.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Description of event: as reported, during an arteriogram of the lower leg via femoral access, a micropuncture transitionless stiffened cannula access set's coaxial system split.The user was able to insert the needle and wire guide into the heavily calcified and scarred groin; however, upon insertion of the coaxial system, both the inner and outer cannulas bent and broke, splitting longitudinally.Resistance was reported upon both insertion and removal of the device.The wire was still in place and the entire complaint device was removed over the wire, abandoning the access site.Another device of the same type was used to access an alternate site and the procedure was completed successfully.Although the patient had undergone multiple previous procedures via groin access, a closure device was not in place.Investigation ¿ evaluation.A document based investigation was performed including a review of complaint history, device history record, drawings, the instructions for use, quality control data, and specifications.The complaint device was not returned; therefore, no physical examinations could be performed.However, a document based investigation evaluation was performed.A review of the device history record found no non-conformances related to the reported failure mode.Because there are 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 field.A review of complaint history records shows no other complaints associated with the complaint device lot.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: precautions ¿do not attempt to insert or withdraw the wire guide and/or introducer if resistance is felt.¿ how supplied: ¿supplied sterilized by ethylene oxide gas in peel-open packages.Intended for one-time use.Sterile if package is unopened or undamaged.Do not use the product if there is doubt as to whether the product is sterile.Store in a dark, dry, and cool place.Avoid extended exposure to light.Upon removal from package, inspect the product to ensure no damage has occurred.¿ 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.Cook has concluded patient anatomy contributed to this incident.As reported, the patient¿s vasculature at the groin area was heavily calcified and scarred due to previous procedures.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 Description

No new patient or event information to report.

• Brand Name: MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET
• Type of Device: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 11362480
• MDR Text Key: 234430764
• Report Number: 1820334-2021-00377
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00827002480032
• UDI-Public: (01)00827002480032(17)230924(10)13451443
• Combination Product (y/n): N
• PMA/PMN Number: K171275
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 04/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/24/2023
• Device Model Number: G48003
• Device Catalogue Number: MPIS-401-10.0-SC-NT-SST
• Device Lot Number: 13451443
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 57 YR