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

Model Number	G35550
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/29/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A follow-up report will be submitted should additional relevant information become available.
Event or Problem Description
As reported, during an urgent coronary angiogram, an unknown component of the micropuncture transitionless stiffened cannula access set separated in the patient, who was reportedly in her early fifties and described as "really restless".Access was obtained in the left side, and as the micropuncture device entered the artery, the patient sat straight up and the unknown component broke off in the patient.The patient was transferred to another hospital for surgical removal of the separated component, which was successfully retrieved.The patient is doing well.Additional information has been requested regarding the event.
Additional Manufacturer Narrative
Additional/corrected information received via medwatch mw 5101726: b2, b3, b5, e4, h6 (annex f).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
Additional information was received via a medwatch report on 22jun2021.The sheath separated, leaving 7.5 centimeters of the sheath in the patient.The separated portion of the sheath was unable to be retrieved with a snare, and vascular surgery was required for removal of the device fragment.
Event or Problem Description
No new patient or event information to report.
Additional Manufacturer Narrative
Description of event: as reported, during an urgent coronary angiogram, an unknown component of the micropuncture transitionless stiffened cannula access set separated in the patient, who was reportedly in her early fifties and described as "really restless".Access was obtained in the left side, and as the micropuncture device entered the artery, the patient sat straight up and the unknown component broke off in the patient.The sheath separated, leaving 7.5 centimeters of the sheath in the patient.The separated portion of the sheath was unable to be retrieved with a snare, and vascular surgery was required for removal of the device fragment.The patient is doing well.Investigation ¿ evaluation: a document based investigation was performed including a review of complaint history, device history record, the instructions for use, manufacturing instructions, 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.There is no evidence to suggest the product was made 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: ¿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 the device failure can be attributed to an adverse event that occurred during the procedure.The patient reportedly sat up during the procedure, after which the device separated.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: 12057209
• Report Number: 1820334-2021-01590
• Device Sequence Number: 4751599
• Product Code: DYB
• UDI-Device Identifier: 00827002355507
• UDI-Public: (01)00827002355507(17)240425(10)13916464
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/01/2021

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: 04/25/2024
• Device Model Number: G35550
• Device Catalogue Number: MPIS-402-10.0-SC-NT-U-SST
• Device Lot Number: 13916464
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/09/2021
• Supplement Date Received by Manufacturer: 06/22/2021; 10/20/2021
• Initial Report FDA Received Date: 06/24/2021
• Supplement Report FDA Received Date: 07/15/2021; 11/01/2021
• 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: Hospitalization; Required Intervention