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

Model Number G56236

Device Problems Difficult to Remove (1528); Material Split, Cut or Torn (4008)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/18/2022

Event Type  Injury  

Event Description

As reported, during an interventional procedure involving the left superficial femoral artery (sfa), a flexor high-flex ansel guiding sheath became stuck in the patient during insertion of the device.Access was obtained in the common femoral artery to target a lesion within the sfa.Resistance was not reported, and the anatomy was not tortuous, calcified, or scarred.The sheath kinked upon advancement over the bifurcation.The user attempted to cross the sheath several times, using multiple wires and catheters, which caused the sheath to become stuck in the iliac artery.The left superficial femoral artery was then accessed percutaneously and a wire and catheter were passed through the sheath in a retrograde fashion.The sheath was then able to be removed, and a new sheath was used to complete the procedure.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

This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.

Event Description

Additional information was received 19may2022.The bifurcation angle was not sharp.The dilator was in place upon initial insertion and advancement of the device.The kink was not noted when the dilator was in place.The user attempted to reinsert the dilator, but it would not advance past the kink.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Summary of event: as reported, during an interventional procedure involving the left superficial femoral artery (sfa), a flexor high-flex ansel guiding sheath became stuck in the patient during insertion of the device.Access was obtained in the common femoral artery to target a lesion within the sfa.Resistance was not reported, and the anatomy was not tortuous, calcified, or scarred.The sheath kinked upon advancement over the bifurcation.The user attempted to cross the sheath several times, using multiple wires and catheters, which caused the sheath to become stuck in the iliac artery.The left superficial femoral artery was then accessed percutaneously, and a wire and catheter were passed through the sheath in a retrograde fashion.The sheath was then able to be removed, and a new sheath was used to complete the procedure.Additional information was received 19may2022.The bifurcation angle was not sharp.The dilator was in place upon initial insertion and advancement of the device.The kink was not noted when the dilator was in place.The user attempted to reinsert the dilator; however, it would not advance past the kink.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.A visual inspection of the complaint device was also conducted.The complaint device was returned to cook for investigation.Five kinks were noted on the sheath at 22cm, 23cm, 23.8cm, 24.3cm, and 43.5cm from the hub.A split was noticed at the fifth kink, where the inner coil could also be seen.A document-based investigation evaluation was performed.There have been no other reported complaints for this lot number.One relevant conformance was noted on a subassembly lot; however, all affected product was scrapped and there are 100% inspections in place to capture the nonconformance.The product ifu warns, ¿reinsertion of dilator prior to removal of flexor sheath increases the strength of the sheath and lessens the risk of device separation.If resistance is anticipated or encountered during withdrawal of flexor sheath, consider carefully reinserting the dilator prior to continuing removal.¿ 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 a component failure unrelated to manufacturing or design deficiencies contributed to this incident.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.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Additional information: b5, d9, h6 (annex a).H3: device evaluated by mfg = other (81) - 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.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

Upon return and initial evaluation of the device, a split was noted in the sheath material, with the inner coils visible through the split.

• Brand Name: FLEXOR HIGH-FLEX ANSEL 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: 14336676
• MDR Text Key: 291208560
• Report Number: 1820334-2022-00698
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00827002562363
• UDI-Public: (01)00827002562363(17)250207(10)14518376
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142829
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/13/2022

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 Model Number: G56236
• Device Catalogue Number: KCFW-6.0-35-55-RB-HFANL1-HC
• Device Lot Number: 14518376
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/18/2022
• Initial Date FDA Received: 05/09/2022
• Supplement Dates Manufacturer Received: 05/09/2022; 05/19/2022
• Supplement Dates FDA Received: 05/16/2022; 06/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/07/2022
• 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
• Treatment: 014 CHOICE PT; 035 GLIDEWIRE; 035 TRAILBLAZER; 4FR IM CATHETER; V18 WIRE
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male