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

Model Number	G11635
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/16/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Occupation = radiology tech.Pma/510(k) number = pre-amendment.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
As reported, during a peripheral transluminal angioplasty with stent placement of the upper left extremity, the hub of a flexor raabe guiding sheath separated at the end of the procedure, as the device was removed.Access was obtained in the left groin using an unknown 7 french, 55 centimeter sheath.The complaint device was in place for two hours.The anatomy was not reported to be tortuous, calcified, or scarred; and resistance was not encountered during insertion or removal of the device.The dilator was not in place at the time of separation and the hub was not used to pull the device from the patient.An unknown wire was in place upon removal of the device.The patient's outcome was reported as "good".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.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
Investigation ¿ evaluation: reviews of the complaint history, device history record, documentation, drawing, instructions for use (ifu), manufacturer¿s instructions, quality control procedures, specifications, and a visual inspection as well as dimensional verification of the returned device were conducted during the investigation.The visual inspection of the returned package confirmed that one used kcfw-7.0-38-70-rb-raabe with the proximal hub separated was returned to cook for investigation.The sheath length, flare, and connector cap¿s inner diameter were all measured, and each was found to be within specification.The cap showed no sheath shaft material.The flare was creased and had a folded section; however, there were no signs of material elongation within 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.Furthermore, reviews of the manufacturer¿s instructions, drawings, specifications, and quality control procedures were conducted, and no gaps were discovered.Moreover, an ifu is provided with the device which states ¿if resistance is encountered during advancement of flexor sheath, 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." it goes on to say "reinsertion of the 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 or flexor sheath, consider carefully reinserting the dilator prior to continuing removal." based on the information provided and the examination of the returned product, investigation has concluded that this event can be traced to the user and unintended use error.Reportedly, the dilator was not in place during the removal of the sheath (per the ifu) when the separation occurred.We will continue our monitoring of similar complaints and have notified the appropriate personnel of this event.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.
Additional 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 or Problem 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
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 9135335
• Report Number: 1820334-2019-02454
• Device Sequence Number: 11218772
• Product Code: DYB
• UDI-Device Identifier: 00827002116351
• UDI-Public: (01)00827002116351(17)211030(10)9272641
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K142829
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/30/2021
• Device Model Number: G11635
• Device Catalogue Number: KCFW-7.0-38-70-RB-RAABE
• Device Lot Number: 9272641
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2019
• Initial Date Received by Manufacturer: 09/17/2019
• Supplement Date Received by Manufacturer: 10/11/2019; 03/24/2020
• Initial Report FDA Received Date: 09/30/2019
• Supplement Report FDA Received Date: 10/18/2019; 03/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1