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

Model Number G44153

Device Problems Migration or Expulsion of Device (1395); Material Separation (1562)

Patient Problem No Code Available (3191)

Event Date 02/21/2018

Event Type  Injury  

Manufacturer Narrative

Pma/510(k) number = preamendment.(b)(4).This report includes information known at this time. a follow-up report will be submitted should additional relevant information become available.

Event Description

It was reported that during treatment of a chronic total occlusion (cto) of the superficial femoral artery (sfa), serial balloon catheter (other manufacturer) inflations were performed along the length of the cto with balloon size escalation.While attempting to exchange the balloon catheter and pass another manufacturer's 5.0 by 100 millimeter (mm) balloon catheter, the 5 fr flexor ansel guiding sheath being utilized fractured at the stem valve and migrated into the patient's right iliac artery.Access was maintained with a wire guide and interventional radiology was used to successfully retrieve the sheath using a 10 mm gooseneck snare (manufacturer unspecified) and 8 fr sheath (manufacturer unspecified) to pull the fractured portion through.The procedure ended at this point and the patient had a large hematoma, which required additional bed rest.The complainant stated that the 5.0 by 100 mm balloon was compatible with the flexor ansel guiding sheath, and that the procedure was 75 percent completed when the sheath fractured; the procedure ended once this event occurred.It was noted that multiple exchanges through the sheath had been performed.The sheath was placed in the right femoral artery via contralateral right to left approach; the patient's vessels were noted to be highly calcified.

Manufacturer Narrative

Investigation ¿ evaluation: a review of the dimensional verification, complaint history, device history record, documentation, manufacturing instructions, quality control, and a visual inspection of the returned device were conducted during the investigation.The visual inspection of the returned device confirmed the that the check-flo valve was separated from the sheath.A length of 1.8 cm of the sheath tubing at the proximal end displayed accordion-like damage.Also, a tear was noted in the sheath tubing a length of 3 mm from the proximal end.The connector cap was removed from the check-flo for further examination, and the flare of the device was found to be contained within the connector cap.The sheath tubing had separated proximal to the start of the coil.A length of 1 mm of tubing was extending distal of the flare.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.Based on the information provided, the examination of the returned product, and the results of our investigation, a definitive root cause could not be determined.Measures are being conducted to address this failure mode.We will continue to monitor for similar complaints.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.Investigation ¿ evaluation: a review of the dimensional verification, complaint history, device history record, documentation, manufacturing instructions, quality control, and a visual inspection of the returned device were conducted during the investigation.The visual inspection of the returned device confirmed the that the check-flo valve was separated from the sheath.A length of 1.8 cm of the sheath tubing at the proximal end displayed accordion-like damage.Also, a tear was noted in the sheath tubing a length of 3 mm from the proximal end.The connector cap was removed from the check-flo for further examination, and the flare of the device was found to be contained within the connector cap.The sheath tubing had separated proximal to the start of the coil.A length of 1 mm of tubing was extending distal of the flare.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.Based on the information provided, the examination of the returned product, and the results of our investigation, a definitive root cause could not be determined.Measures are being conducted to address this failure mode.We will continue to monitor for similar complaints.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 Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

Manufacturer Narrative

Correction: d1, d4, g5, h4.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 ANSEL GUIDING SHEATH
• Type of Device: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7299745
• MDR Text Key: 101058427
• Report Number: 1820334-2018-00576
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00827002441538
• UDI-Public: (01)00827002441538(17)201218(10)8453687
• Combination Product (y/n): N
• PMA/PMN Number: K142829
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 03/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/18/2020
• Device Model Number: G44153
• Device Catalogue Number: KCFW-5.0-18/38-45-RB-ANL0-HC
• Device Lot Number: 8453687
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention