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

Model Number G12835

Device Problem Fluid/Blood Leak (1250)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 06/24/2022

Event Type  Injury  

Manufacturer Narrative

Initial customer name, address and phone: (b)(6).This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.

Event Description

As reported, a flexor shuttle tibial guiding sheath became loose and leaked blood from the y-connector.The patient underwent angiography, aspiration of thrombus, and angioplasty of the right upper limb.After the procedure, the patient returned to the room and was treated with an indwelling "artery thrombolytic tube".The complaint device was reportedly inserted into the patient on (b)(6) 2022.The last dose of thrombolytic (urokinase) was administered two days later ((b)(6) 2022) at 11 am, after which the arterial catheter was removed and the complaint sheath was "fixed" in position.Per the user, the complaint device was removed on (b)(6) 2022; however, the user also reported that at 12:35 am on (b)(6) 2022, the nurse noted that the "y valve" was loose and arterial blood was flowing from the sheath.The user reported two-thirds of blood stains on the sheets were fresh.The nurse replaced the valve and no further bleeding was noted.The patient remained conscious without obvious signs of discomfort.The patient's blood pressure was 151/108 and the heart rate was 70 beats per minute.The patient's hemoglobin was 9.8g/dl.Reportedly, 1.5 units of blood was administered later the same day and again the following day.The patient was discharged six days after the original angiography procedure.An infusion pump was not used with the sheath.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.

Manufacturer Narrative

Summary of event: as reported, a flexor shuttle tibial guiding sheath became loose and leaked blood from the y-connector.The patient underwent angiography, aspiration of thrombus, and angioplasty of the right upper limb.After the procedure, the patient returned to the room and was treated with an indwelling "artery thrombolytic tube".The complaint device was reportedly inserted into the patient on (b)(6) 2022.The last dose of thrombolytic (urokinase) was administered two days later ((b)(6) 2022) at 11 am, after which the arterial catheter was removed, and the complaint sheath was "fixed" in position.Per the user, the complaint device was removed (b)(6) 2022; however, the user also reported that at 12:35 am on 27jun2022, the nurse noted that the "y valve" was loose and arterial blood was flowing from the sheath.The user reported two-thirds of blood stains on the sheets were fresh.The nurse replaced the valve, and no further bleeding was noted.The patient remained conscious without obvious signs of discomfort.The patient's blood pressure was 151/108 and the heart rate was 70 beats per minute.The patient's hemoglobin was 9.8g/dl.Reportedly, 1.5 units of blood was administered later the same day and again the following day.The patient was discharged six days after the original angiography procedure.An infusion pump was not used with the sheath.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.Investigation evaluation: reviews of the complaint history, device history record, instructions for use (ifu), and quality control procedures were conducted during the investigation.The complaint device was not returned to cook for investigation.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.The product ifu states that the intended use of the device is to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.The ifu states that the product is intended for use by physicians trained and experienced in diagnostic and interventional techniques, and that standard techniques for placement of vascular access sheaths should be employed.The information provided upon review of the dmr, dhr, and ifu suggests that there is evidence the device was manufactured to specification.There is no evidence of non-conforming devices in-house or in the field.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 unintended user error likely contributed to this event, as the sheath was left in the patient for two-to-three days, with an indwelling "artery thrombolytic tube" in place.Although the ifu does not specifically instruct the user not to leave the sheath in place after the intended procedure, it does state that the device is intended to introduce other medical devices.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.

Event Description

No additional information has been received since the last report was submitted.

• Brand Name: FLEXOR SHUTTLE TIBIAL GUIDING SHEATH
• Type of Device: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 15113921
• MDR Text Key: 296697924
• Report Number: 1820334-2022-01288
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00827002128354
• UDI-Public: (01)00827002128354(17)230925(10)13452531
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K142819
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/01/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 09/25/2023
• Device Model Number: G12835
• Device Catalogue Number: KSAW-7.0-38-90-RB-SHTL-HC
• Device Lot Number: 13452531
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/13/2022
• Initial Date FDA Received: 07/27/2022
• Supplement Dates Manufacturer Received: 10/13/2022
• Supplement Dates FDA Received: 11/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/25/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR
• Patient Sex: Male