MAUDE Adverse Event Report: COOK INC FLEXOR INTRODUCER SHEATH; DYB INTRODUCER, CATHETER

Model Number	G08681
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/24/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Occupation: radiology tech.Pma/510(k) number: pre-amendment.A follow-up report will be submitted should additional relevant information become available.
Event or Problem Description
As reported, during a left lower extremity angiogram with intervention via left antegrade access, the valve of a flexor introducer sheath leaked.Per the reporter, the device leaked continuously, including when nothing was inserted into the valve, after insertion but prior to removal.A cook cxi catheter and uniglide 0.035 inch wire guide were used through the sheath, which was in place for five minutes.The anatomy was not reported to be tortuous and resistance was not encountered.Blood loss was reported, although it was "not significant".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.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Investigation ¿ evaluation.Reviews of the complaint history, device history record, documentation, drawing, instructions for use (ifu), manufacturer¿s instructions, quality control procedures, and a visual inspection/functional test of the returned device were conducted during the investigation.The visual inspection of the returned package confirmed that one used kcfw-6.0-38-rb sheath without the dilator was returned to cook for investigation.Biomatter was present throughout the device.Hemostats were used to occlude the sheath tip to perform a leak test of the valve using a syringe and water.The device did not leak.The hub was unscrewed to inspect the check-flo silicone disk for damage, but none was noted.Additionally, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.A review of the device history record showed no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.Furthermore, reviews of the manufacturer¿s instructions, drawings, and quality control procedures were conducted, and no gaps were discovered.Moreover, an ifu is provided with this device, which states ¿upon removal from package, inspect the product to ensure no damage has occurred.¿ it goes on to note ¿using the side-arm of the valve, flush the sheath by filling the sheath assembly completely with heparinized saline.¿ based on the information provided and the examination of the returned product, investigation has concluded that a root cause could not be established.We will continue our monitoring of similar complaints and have 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.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 additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
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
This mdr is being submitted as having information not previously reported.Additional complaint investigation and record remediation was not performed.Blank fields on this form indicate the information is unknown or unavailable.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: FLEXOR INTRODUCER SHEATH
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 9246093
• Report Number: 1820334-2019-02702
• Device Sequence Number: 16245600
• Product Code: DYB
• UDI-Device Identifier: 00827002086814
• UDI-Public: (01)00827002086814(17)220910(10)10001465
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K142829
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/25/2020

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: 09/10/2022
• Device Model Number: G08681
• Device Catalogue Number: KCFW-6.0-38-RB
• Device Lot Number: 10001465
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2019
• Initial Date Received by Manufacturer: 10/24/2019
• Supplement Date Received by Manufacturer: 11/13/2019; 03/25/2020
• Initial Report FDA Received Date: 10/28/2019
• Supplement Report FDA Received Date: 11/22/2019; 03/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1