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

Model Number	G36393
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/02/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant products= zisl-16-59; zisl-16-77; zimb-28-98; ziv6-80-14-4.0; zisl-13-42; zbis-12-45-41; cook 12 fr ansel sheath; terumo 260 wire; bentley begraft aortic stent graft system bga5912_1.(b)(6).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 an iliac branch procedure to treat an iliac aneurysm, a flexor raabe guiding sheath separated.Reportedly, an unspecified cook 12 french ansel sheath was in place and the user attempted to load another manufacturer's "12mm x 57" aortic stent graft into the 9 french complaint device, outside of the body, over another manufacturer's wire guide.The "yellow" protector included with the other manufacturer's aortic stent graft was reportedly not used for insertion; therefore, the stent dislodged from the balloon.The balloon was remounted with "some effort" and was then loaded, using the protector, into the sheath, which was reported to be "damaged" at that time.The sheath was then used to deploy the stent successfully.Upon removal of the device, it was noted to be separated.Per the reporter, "excessive strain" was put on the sheath.The procedure was completed successfully.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.
Additional Manufacturer Narrative
Investigation - evaluation.Reviews of the complaint history, device history record, drawing, instructions for use, manufacturing instructions, quality control procedures, and specifications, and a visual inspection and a dimensional verification of the returned device were conducted during the investigation.One flexor raabe guiding sheath was returned for investigation.Visual inspection showed biomatter throughout.Another manufacturer¿s balloon was lodged in the sheath, and the sheath was separated at the hub.Coils were exposed at the separation point, and the strain relief was still attached to the hub.Some sheath material remained inside the strain relief, indicative of separation of the sheath material.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, specifications, drawing, and quality control procedures were conducted, and no gaps were discovered.The device is packaged with instructions for use, which state, "if resistance is anticipated or encountered during withdrawal of the flexor sheath, consider reinserting the dilator and removing the sheath and dilator as a unit." based on the information provided and the examination of the returned product, investigation has concluded that the device failure is likely attributable to uncommon stresses applied to the sheath as a result of multiple attempts to re-sheath another manufacturer¿s stent.Measures are being conducted to address this failure mode.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.
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
G5: pma/510(k) = k142829.This mdr is being submitted as having information not previously reported.Additional complaint investigation and record remediation was not performed.Event summary: as reported, during treatment of an iliac aneurysm, a flexor raabe guiding sheath separated.Reportedly, an unspecified cook 12 french ansel sheath was in place and the user attempted to load another manufacturer's "12mm x 57" aortic stent graft into the 9 french complaint device, outside of the body, over another manufacturer's wire guide.The "yellow" protector included with the other manufacturer's aortic stent graft was reportedly not used for insertion; therefore, the stent dislodged from the balloon.The balloon was remounted with "some effort" and was then loaded, using the protector, into the sheath, which was reported to be "damaged" at that time.The sheath was then used to deploy the stent successfully.Upon removal of the device, it was noted to be separated.Per the reporter, "excessive strain" was put on the sheath.The procedure was completed successfully.Investigation ¿ evaluation: reviews of the complaint history, device history record, drawing, instructions for use, manufacturing instructions, quality control procedures, and specifications, and a visual inspection and a dimensional verification of the returned device were conducted during the investigation.One flexor raabe guiding sheath was returned for investigation.Visual inspection showed biomatter throughout.Another manufacturer¿s balloon was lodged in the sheath, and the sheath was separated at the hub.Coils were exposed at the separation point, and the strain relief was still attached to the hub.Some sheath material remained inside the strain relief, indicative of separation of the sheath material.Additionally, a document-based investigation evaluation was performed.A review of the device history record showed no non-conformances related to this incident.Because there are no related non-conformances, adequate inspection activities have been established, there is objective evidence that the device history record was fully executed, and no other lot related complaints that have been received from the field, it was concluded that there is no evidence that nonconforming product exists in house or in the field.The complaint lot was manufactured to current specifications.The device is packaged with instructions for use, which state, "if resistance is anticipated or encountered during withdrawal of the flexor sheath, consider reinserting the dilator and removing the sheath and dilator as a unit." based on the information provided and the examination of the returned product, investigation has concluded that the device failure is likely attributable to uncommon stresses applied to the sheath as a result of multiple attempts to re-sheath another manufacturer¿s stent.At the time of the investigation, a capa was in place to investigate this failure mode.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.
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: 9535442
• Report Number: 1820334-2019-03164
• Device Sequence Number: 11610340
• Product Code: DYB
• UDI-Device Identifier: 00827002363939
• UDI-Public: (01)00827002363939(17)220920(10)10028053
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/10/2020

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: 09/20/2022
• Device Model Number: G36393
• Device Catalogue Number: KCFW-9.0-38-55-RB-RAABE
• Device Lot Number: 10028053
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2019
• Initial Date Received by Manufacturer: 12/05/2019
• Supplement Date Received by Manufacturer: 01/17/2020; 03/10/2020
• Initial Report FDA Received Date: 12/31/2019
• Supplement Report FDA Received Date: 01/24/2020; 03/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 78 YR