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

Model Number	G47701
Medical Device Problem Codes	Material Separation (1562); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/16/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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
It was reported, during an aortic stent graft procedure the dilator portion of the flexor high-flex ansel guiding sheath device became separated near the hub.According to the initial reporter, the dilator was in place with an unspecified wire guide, or other device, inserted in the lumen when the separation occurred.However, the sheath and dilator were not withdrawn as a unit.It was provided that no resistance was felt during the insertion or removal process of the dilator, and upon the separation of the hub, the complaint device was able to be removed from the patient's anatomy without issue using cautery forceps.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
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Additional information b5: additional information was received on 15jan2019, noting that the physician had no difficulty inserting the dilator into the sheath.Additionally, the anatomy was not tortuous, but "normal".Investigation ¿ evaluation.A review of the dimensional verification, complaint history, device history record, manufactures instructions, quality control, specifications, and a visual inspection of the returned device was conducted during the investigation.The visual inspection of the returned device confirmed that the dilator was also returned used.There was biomatter throughout the device.The dilator¿s proximal fitting and introducer sheath were not returned.The dilator flare was intact and in-round.The shaft¿s outer diameter varies from.161¿ to.163¿ at different locations of the shaft, indicating that the shaft was not in round.There was no notable damage to the dilator shaft, however the outer diameter was found to be out of specifications.Additionally, a document based investigation evaluation was performed.There is 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.However, it should be noted that during a review of the sub assembly lot sa8269753 a related nonconformance for hubs separating on the dilators during uv curing was found.It should also be noted there were no other reported complaints for this lot number.There is also no evidence of additional complaints or nonconforming product from this lot in the field.Furthermore, a review of the manufactures instructions and quality control procedures was conducted, and no gaps were discovered.Based on the information provided, the examination of the returned product, and the results of our investigation, a definitive root cause could not be established.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
Please see h10 for additional information.
Additional Manufacturer Narrative
B2 age: 30 years old.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 or Problem Description
Additional information regarding the patient and/or event has been received since the previous medwatch report was sent.This information is detailed in section h10.
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
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.This mdr is being submitted as having information not previously reported.Additional complaint investigation and record remediation was not performed.Summary of event: it was reported, during an aortic stent graft procedure the dilator portion of the flexor high-flex ansel guiding sheath device became separated near the hub.According to the initial reporter, the dilator was in place with an unspecified wire guide, or other device, inserted in the lumen when the separation occurred.However, the sheath and dilator were not withdrawn as a unit.No resistance was felt during the insertion or removal process of the dilator, and upon the separation of the hub, the complaint device was able to be removed from the patient's tortuous but "normal" anatomy without issue using cautery forceps.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.Corrected information: g5: 510k= k142829.H6: device code, conclusion code.H10: investigation-evaluation.Investigation - evaluation: a review of the dimensional verification, complaint history, device history record, manufacturer¿s instructions, quality control, specifications, and a visual inspection of the returned device was conducted during the investigation.The visual inspection of the returned device confirmed that the dilator was returned used.There was biomatter throughout the device.The dilator¿s proximal fitting and introducer sheath were not returned.The dilator flare was intact and in-round.The shaft¿s outer diameter varies from.161¿ to.163¿ at different locations of the shaft, indicating that the shaft was not in round.There was no notable damage to the dilator shaft, however the outer diameter was found to be out of specification.Additionally, a document-based investigation evaluation was performed.A review of the device history record showed no nonconforming events on the finished product lot.However, it should be noted that during a review of the sub assembly lot sa8269753, a related nonconformance for hubs separating on the dilators during uv curing was found.The nonconforming devices were scrapped and not replaced.It should also be noted there were no other reported complaints for this lot number.There is also no evidence of additional complaints or nonconforming product from this lot in the field.At the time of the investigation, a capa was in place to investigate this failure mode.The investigation determined that adequate controls were not in place to prevent this failure mode.Results of the capa determined the root cause to be related to deficiencies in manufacturing and validation.Action plans were developed to address the root causes.Based on the information provided, the examination of the returned product, and the results of our investigation, a definitive root cause could not be established, though the device failure was likely related to deficiencies in manufacturing and validation.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 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.

• Brand Name: FLEXOR HIGH-FLEX ANSEL GUIDING SHEATH
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8063427
• Report Number: 1820334-2018-03213
• Device Sequence Number: 1991588
• Product Code: DYB
• UDI-Device Identifier: 00827002477018
• UDI-Public: (01)00827002477018(17)201116(10)8379355
• 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,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: 11/16/2020
• Device Model Number: G47701
• Device Catalogue Number: KCFW-12.0-35-45-RB-HFANL1-HC
• Device Lot Number: 8379355
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2018
• Initial Date Received by Manufacturer: 10/16/2018
• Supplement Date Received by Manufacturer: 12/05/2018; 01/14/2019; 01/14/2019
• Initial Report FDA Received Date: 11/13/2018
• Supplement Report FDA Received Date: 12/20/2018; 01/15/2019; 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: 30 YR