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

Model Number	G48004
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter occupation = catheterization lab.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.
Event or Problem Description
As reported, during a peripheral endovascular intervention, the wire of a micropuncture transitionless stiffened cannula access set was frayed.Access was gained with the needle in the set in the femoral vein, which was not scarred or calcified.When advancing the microwire under ultrasound, the wire was observed frayed.The wire was manipulated through the entry needle.There no reported resistance during insertion of the wire.The needle and wire were removed, and another of the same set was used to complete the procedure with no further complications.The wire did not kink or present any sharp edges.The device was returned 15apr2021.The needle and wire were received stuck together.The wire was separated, resulting in coil elongation.A section of the device did not remain inside the patient¿s body.The patient did not require any additional intervention due to this occurrence.The patient did not experience any adverse effects due to this occurrence.
Event or Problem Description
No new patient or event information to report.
Additional Manufacturer Narrative
Description of event: as reported, during a peripheral endovascular intervention, the wire of a micropuncture transitionless stiffened cannula access set was frayed.Access was gained with the needle in the set in the femoral vein, which was not scarred or calcified.When advancing the microwire under ultrasound, the wire was observed frayed.The wire was manipulated through the entry needle.There no reported resistance during insertion of the wire.The needle and wire were removed, and another of the same set was used to complete the procedure with no further complications.The wire did not kink or present any sharp edges.Investigation ¿ evaluation.A visual inspection of the returned device was conducted.A document based investigation was also performed including a review of complaint history, device history record, drawings, the instructions for use, manufacturing instructions, and quality control data.The complainant returned one used mpis-401-10.0-sc-nt-u-sst to cook for investigation.Physical examination of the returned device showed: the needle and wire received stuck together.The wire was separated resulting in coil elongation.Bio-matter seen on the distal end of the needle.There is no evidence from device failure analysis that the complaint was manufactured out of specification.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.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.¿ ¿withdrawal or manipulation of the distal spring coil portion of the mandril wire guide through a needle tip may result in breakage.¿ 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 that component failure unrelated to manufacturing or design deficiencies contributed to this incident.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.

• 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: 11686337
• Report Number: 1820334-2021-01159
• Device Sequence Number: 14224327
• Product Code: DYB
• UDI-Device Identifier: 00827002480049
• UDI-Public: (01)00827002480049(17)240129(10)13727582
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/09/2021

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: 01/29/2024
• Device Model Number: G48004
• Device Catalogue Number: MPIS-401-10.0-SC-NT-U-SST
• Device Lot Number: 13727582
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2021
• Initial Date Received by Manufacturer: 04/08/2021
• Supplement Date Received by Manufacturer: 08/24/2021
• Initial Report FDA Received Date: 04/19/2021
• Supplement Report FDA Received Date: 09/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1