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

Model Number G47944

Device Problem Unraveled Material (1664)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/16/2020

Event Type  malfunction  

Manufacturer Narrative

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, while using a micropuncture transitionless access set, the wire guide became unraveled.The needle was inserted into the patient by femoral approach.After inserting the wire guide into the needle, the physician felt resistance when advancing the sheath/introducer over the wire guide.They then removed the wire guide and noted the unraveled wire.Therefore, another device was used to complete the procedure.There have been no adverse effects to the patient reported.

Manufacturer Narrative

Description of event: as reported, while using a micropuncture transitionless access set, the wire guide became unraveled.The needle was inserted into the patient by femoral approach.After inserting the wire guide into the needle, the physician felt resistance when advancing the sheath/introducer over the wire guide.They then removed the wire guide and noted the unraveled wire.Therefore, another device was used to complete the procedure.There have been no adverse effects to the patient reported.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, documentation, the instructions for use, manufacturing instructions, and quality control data.One wire was received.The solder connection at the distal tip was broken broke resulting in coil elongation.No further issues were identified during the analysis.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: ¿withdrawal or manipulation of the distal spring coil portion of the mandril wire guide through a needle tip may result in breakage.¿ instructions for use: ¿2.Advance the.018 inch wire guide through the introducer needle.Caution: do not withdraw the wire guide through the introducer needle; breakage may result.If the wire guide tip must be withdrawn while the needle is inserted, remove both the needle and the wire as a unit.3.Withdraw the introducer needle, leaving the wire guide in place.¿ 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.Based on the investigation results, there is evidence to support that the device was manufactured to specification.Cook has concluded that component failure unrelated to manufacturing or design deficiencies contributed to the failure.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 ACCESS SET
• Type of Device: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 11046029
• MDR Text Key: 246835992
• Report Number: 1820334-2020-02347
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00827002479449
• UDI-Public: (01)00827002479449(17)230822(10)13384395
• Combination Product (y/n): N
• PMA/PMN Number: K171275
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 04/22/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 08/22/2023
• Device Model Number: G47944
• Device Catalogue Number: MPIS-401-NT-U-SST
• Device Lot Number: 13384395
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2021
• Initial Date Manufacturer Received: 03/31/2021
• Initial Date FDA Received: 12/21/2020
• Supplement Dates Manufacturer Received: 03/31/2021
• Supplement Dates FDA Received: 04/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1