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

Model Number	G48006
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/09/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pma/510(k) number = k171275.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 cardiac catheterization involving a (b)(6) year old male with a history of acute respiratory failure and hypertension, a wire guide included in the micropuncture transitionless stiffened cannula access set separated and was retained in the patient.Additional information regarding event details and outcome has been requested, but is not available at this time.
Event or Problem Description
Additional information: the event was reported to the fda by the user facility.Medwatch mw5089895 was received by the manufacturer 07oct2019.There are no additional details in the medwatch report.
Additional Manufacturer Narrative
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 or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
D10, h3: the complaint device was not returned for investigation.Investigation ¿ evaluation: a review of the complaint history, device history record, documentation, drawing, manufacturing instructions, and quality control of the device was conducted during the investigation.The complaint device was not returned, and no photos of the device were provided; therefore, a visual inspection of the complaint device was not conducted.A document-based investigation evaluation was performed during the investigation.There is no evidence to suggest the product was not made to specifications.While one nonconformance was found that could contribute to this failure mode, all affected units were scrapped and not replaced.It should also be noted that there are no other complaints associated with this lot number.Furthermore, a review of the manufactures instructions, and quality control procedures was conducted, and no gaps were discovered.A drawing is included with the device labeling, warning the user not to pull the distal spring coil portion of the wire guide through a needle tip.Based on the information provided, no returned product and the results of the investigation, a root cause could not be established.Cook will continue to monitor for similar complaints and has notified the appropriate personnel of this event.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 STIFFENED CANNULA ACCESS SET
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 9161318
• Report Number: 1820334-2019-02542
• Device Sequence Number: 2057463
• Product Code: DYB
• UDI-Device Identifier: 00827002480063
• UDI-Public: (01)00827002480063(17)220722(10)9895546
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/22/2022
• Device Model Number: G48006
• Device Catalogue Number: MPIS-501-10.0-SC-SST
• Device Lot Number: 9895546
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/23/2019
• Supplement Date Received by Manufacturer: 10/07/2019; 01/14/2020
• Initial Report FDA Received Date: 10/07/2019
• Supplement Report FDA Received Date: 10/29/2019; 01/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 65 YR