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

Model Number	G44154
Medical Device Problem Codes	Stretched (1601); Unraveled Material (1664); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/25/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, during an aortogram via contralateral access, performed prior to placement of a stent within the superficial femoral artery, a flexor ansel guiding sheath stretched and unraveled at the tip upon removal of the device.The dilator was not reinserted prior to removal of the sheath.The patient was transferred to a hospital for surgical removal of the device.The patient was reportedly doing well the following morning.Upon return and initial evaluation of the device, the hub was also noted to be separated.
Additional Manufacturer Narrative
Occupation: lab manager.Device evaluated by mfg - device evaluation has begun; however, a conclusion is not yet available.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
Additional information was received 10feb2022.A 6 french short sheath was used to obtain access in the left groin and was then exchanged, over another manufacturer's wire, for the complaint device.The patient had a history of multiple angiograms in the past, and advancement of the sheath was reportedly difficult due to scarring and a large amount of fat in the groin area.The sheath did cross over to the right common iliac artery; however, when the dilator was removed, the hub of the sheath separated.Manual pressure was held, and a standard j-wire wire was inserted into the shaft of the sheath to remove and replace the sheath.While pulling the sheath out, it unraveled and separated, leaving coils hanging from the access site.Manual pressure was held by the surgical tech and vascular surgery was consulted.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Additional information: b5, d10- concomitant products: kcfw-6.0-18/38-45-rb-anlo-hc lot14076238, boston scientific amplatz super stiff 0.035 x 180 lot24202673, angiodynamics soft vu racket 5f 65cm ref (b)(4).Summary of event: as reported, during an aortogram via contralateral access, performed prior to placement of a stent within the superficial femoral artery, a flexor ansel guiding sheath stretched and unraveled at the tip upon removal of the device.A 6 french short sheath was used to obtain access in the left groin and was then exchanged, over another manufacturer's wire, for the complaint device.The patient had a history of multiple angiograms in the past, and advancement of the sheath was reportedly difficult due to scarring and a large amount of fat in the groin area.The sheath did cross over to the right common iliac artery; however, when the dilator was removed, the hub of the sheath separated.Manual pressure was held, and a standard j-wire was inserted into the shaft of the sheath to remove and replace the sheath.While pulling the sheath out, it unraveled and separated, leaving coils hanging from the access site.Manual pressure was held by the surgical tech and vascular surgery was consulted.The patient was transferred to a hospital for surgical removal of the device.The patient was reportedly doing well the following morning.Investigation evaluation: a review of the complaint history, device history record, instructions for use (ifu), manufacturing instructions, and quality control procedures was conducted during the investigation.A visual inspection of the complaint device was also conducted.The complaint device was returned to cook for investigation.The hub was separated from the sheath, and the distal tip of the sheath was elongated and uncoiled, with metal wire exposed.A document-based investigation evaluation was performed.One relevant non-conformance was noted; however, the product was scrapped.There are 100% inspections in place to capture the failure mode.There have been no other reported complaints for this lot number.The product ifu states that if resistance is encountered during sheath advancement, ¿assess cause of resistance and consider dilation of any restriction identified or consider alternate treatment strategy.If flexor sheath is advanced through resistance, force to remove the sheath will be higher, increasing the risk of sheath material or hub separation upon withdrawal¿.The ifu also states that reinsertion of the dilator prior to removal of the sheath ¿increases the strength of the sheath and lessens the risk of device separation¿ and suggests insertion of the dilator prior to removal if resistance is encountered or anticipated during withdrawal of the device.The information provided upon review of the dmr, dhr, ifu, and investigation of the returned device 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 the patient¿s anatomy could have contributed to this failure mode, as it was stated the groin was scarred from multiple previous procedures and resistance was reported upon advancement.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: FLEXOR ANSEL GUIDING SHEATH
• Common Device Name: 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: 12788634
• Report Number: 1820334-2021-02475
• Device Sequence Number: 4840303
• Product Code: DYB
• UDI-Device Identifier: 00827002441545
• UDI-Public: (01)00827002441545(17)240616(10)14029129
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K142829
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/03/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/16/2024
• Device Model Number: G44154
• Device Catalogue Number: KCFW-6.0-18/38-45-RB-ANL0-HC
• Device Lot Number: 14029129
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/26/2021
• Supplement Date Received by Manufacturer: 02/10/2022
• Initial Report FDA Received Date: 11/10/2021
• Supplement Report FDA Received Date: 03/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/16/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown