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

Model Number G12266

Device Problems Difficult to Insert (1316); Material Separation (1562)

Patient Problems Thrombosis (2100); No Code Available (3191)

Event Date 01/24/2018

Event Type  Injury  

Manufacturer Narrative

(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 a left leg angioplasty, the flexor raabe guiding sheath separated approximately thirty (30) centimeters (cm) away from the hub upon removal.A portion of sheath remained inside of the patient's anatomy; the patient was taken to the hospital for a cut down, and the device portion was able to be successfully retrieved.It was noted that the patient's vessels were calcified.The access site was reported to be very heavily scarred resulting in difficulty during insertion of the sheath.A balloon catheter (manufacturer unspecified), and wire guide (manufacturer unspecified) were utilized through the sheath during the procedure.The sheath was placed in the patient's right femoral groin; access was gained via a contralateral approach.

Manufacturer Narrative

It was later reported by the customer that the patient experienced two additional thrombolysis procedures, and that following these procedures, the patient is doing ok.The patient continues to be monitored to ensure that the affected vessel remains open.Investigation ¿ evaluation: a review of the dimensional verification, complaint history, device history record, documentation, drawing, instructions for use (ifu), quality control, and a visual inspection of the returned device were conducted during the investigation.The visual inspection of the returned device confirmed that the device was separated into three sections.The first tubing section (proximal) measured 43.4 cm in length, followed by 19.0 cm of exposed coil.The second tubing section (middle) measured 3.9 cm in length, followed by 4.2 cm of exposed coil.The third tubing section (distal) measured 54.0 cm in length, with 3.4 cm of exposed coil exiting the proximal end.The most proximal tubing segment had accordion damage at the 28.5 cm and 35.5 cm marks, as measured from the proximal fitting.The tubing also appeared to be elongated.There were separated pieces of sheath liner embedded in the coil exiting the distal end of the second tubing segment.Multiple hemostat marks were observed on the distal end of the third tubing segment.The distal tip of the sheath was also wrinkled.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.

Manufacturer Narrative

Additional information: device evaluation begun, but is not yet complete.It was reported that although the sheath was successfully removed, the patient was reported to have some issues with thrombosis after the procedure.The physician stated that he is working on removing the clot and restoring blood flow.(b)(4).This report includes information known at this time. a follow-up report will be submitted should additional relevant information become available.

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.

Event Description

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

• Brand Name: FLEXOR RAABE GUIDING SHEATH
• Type of Device: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7234011
• MDR Text Key: 98781949
• Report Number: 1820334-2018-00337
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00827002122666
• UDI-Public: (01)00827002122666(17)201130(10)8409382
• 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,user f
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2020
• Device Model Number: G12266
• Device Catalogue Number: KCFW-6.0-38-90-RB-RAABE
• Device Lot Number: 8409382
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 76 YR