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

Model Number	G36333
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	10/28/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).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 left cardiac catheterization and femoral artery angiogram via groin access, a micropuncture transitionless access set was used for post angioseal deployment.The inner cannula was inserted and on injection, the hub of the cannula separated from the device.The device had been in place for thirty seconds.The cannula remained in the femoral artery.A minor cut-down procedure was performed and the cannula was removed without difficulty.Another device was then used.The patient was reportedly stable.A section of the device did not remain inside the patient¿s body.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
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
Additional information was received 24nov2020.Access was obtained in the femoral artery, using the compliant device.A micropuncture wire and another manufacturer¿s sheath were used with the device.No complications were noted with the other manufacturer's sheath.
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
Summary of event: as reported, during a left cardiac catheterization and femoral artery angiogram via groin access, a micropuncture transitionless access set was used for post angioseal deployment.The inner cannula was inserted and on injection, the hub of the cannula separated from the device.The device had been in place for thirty seconds.The cannula remained in the femoral artery.A minor cut-down procedure was performed, and the cannula was removed without difficulty.Another device was then used.The patient was reportedly stable.Access was obtained in the femoral artery, using the compliant device.A micropuncture wire and another manufacturer¿s sheath were used with the device.No complications were noted with the other manufacturer's sheath.A section of the device did not remain inside the patient¿s body.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Investigation evaluation: reviews of the complaint history, device history record, documentation, manufacturing instructions, quality control, and specifications were conducted during the investigation.The complaint device was not returned to cook for investigation.Unused devices from the same lot were returned, however, and none of the unused devices were separated.A document-based investigation evaluation was performed.No related non-conformances were found, and there have been no other reported complaints for this lot number.From the information provided upon review of the dmr, dhr, dhf, ifu, and returned unused devices, cook concluded that the device was manufactured to specification, and that there are no nonconforming devices in house or out in the field.The product ifu states ¿when inserting, manipulating or withdrawing a device through an introducer, always maintain introducer position¿ and ¿do not attempt to insert or withdraw the wire guide and/or introducer if resistance is felt¿.Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.Based on the information provided and the results of the investigation, cook has concluded that a component failure contributed to the failure mode.The risk analysis for this failure mode was reviewed and no additional escalation was required.The appropriate personnel have been notified and cook will continue to monitor for similar events.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 ACCESS SET
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 10854519
• Report Number: 1820334-2020-02130
• Device Sequence Number: 11796058
• Product Code: DYB
• UDI-Device Identifier: 00827002363335
• UDI-Public: (01)00827002363335(17)230729(10)13335595
• Combination Product (Y/N): N
• Initial Reporter State: ME
• 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,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/18/2021

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: 07/29/2023
• Device Model Number: G36333
• Device Catalogue Number: MPIS-501-SST
• Device Lot Number: 13335595
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/29/2020
• Supplement Date Received by Manufacturer: 11/24/2020; 02/10/2021
• Initial Report FDA Received Date: 11/17/2020
• Supplement Report FDA Received Date: 12/21/2020; 02/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PRELUDE SHEATH.
• Outcome Attributed to Adverse Event: Required Intervention