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

Model Number	G56202
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Occupation = ir technologist.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, a micropuncture traditionless access set's wire sheared while obtaining access for femoral line placement.The user reported that the wire was not as smooth as normal at the distal tip.Another device of the same type was used to complete the procedure successfully.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.
Event or Problem Description
Additional information was received 24feb2021.The patient did not require hospitalization due to this occurrence.
Additional Manufacturer Narrative
Additional information: b3, b5, d10, h3.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.
Additional Manufacturer Narrative
Description of event: as reported, a micropuncture transitionless access set's wire sheared while obtaining access for femoral line placement.The user reported that the wire was not as smooth as normal at the distal tip.Another device of the same type was used to complete the procedure successfully.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, quality control data, and specifications.Three (pmg-18-40-mpis-c) wires were received.One wire had a broken solder connection causing the coil to become elongated.The tip connection was present.The second wire had off set coils at 1.9cm from distal tip.The third wire was unused and was not damaged.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: 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.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 a component failure unrelated to design or manufacturing deficiencies was the cause of this complaint.The investigation result provide evidence to support that the devices were manufactured to specification.One of the wires from the complaint lot was returned sealed in the packaging, the wire was opened and no damage was noted.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 or Problem Description
No new patient or event information to report.

• Brand Name: MICROPUNCTURE TRANSITIONLESS ACCESS SET
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 11306935
• Report Number: 1820334-2021-00292
• Device Sequence Number: 16958015
• Product Code: DYB
• UDI-Device Identifier: 00827002562028
• UDI-Public: (01)00827002562028(17)231207(10)13610630
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K171275
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/04/2021

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: 12/07/2023
• Device Model Number: G56202
• Device Catalogue Number: MPIS-502-NT-U-SST
• Device Lot Number: 13610630
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2021
• Initial Date Received by Manufacturer: 02/03/2021
• Supplement Date Received by Manufacturer: 02/24/2021; 05/07/2021
• Initial Report FDA Received Date: 02/10/2021
• Supplement Report FDA Received Date: 02/26/2021; 06/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1