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

Model Number	G56236
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/29/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pma/510(k) number: pre-amendment.A follow-up report will be submitted should additional relevant information become available.
Event or Problem Description
As reported, during an angioplasty procedure, a flexor high-flex ansel guiding sheath separated into two pieces at the shaft.The dilator was not in place at the time of separation.All pieces were successfully retrieved and another device was used to complete the procedure successfully.The patient's outcome is reported to be "as expected".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
Summary of event: as reported, during an angioplasty procedure, a flexor high-flex ansel guiding sheath separated into two pieces at the shaft.The dilator was not in place at the time of separation.All pieces were successfully retrieved, and another device was used to complete the procedure successfully.Corrected information: g5: 510(k)= k142829.H10: investigation-evaluation.Investigation - evaluation: reviews of the complaint history, device history record, documentation, drawing, instructions for use (ifu), specifications, manufacturing instructions, and quality control procedures and a visual inspection of the returned device were conducted during the investigation.One flexor high-flex ansel guiding sheath was returned for investigation.Visual inspection showed biomatter present on the device.The sheath was kinked at 30.8cm from the fitting.The sheath material was separated at 46.9cm from the hub.The separated section measured 8cm.One coil was exposed at the separation site.No other damage was noted.Additionally, a document-based investigation evaluation was performed.A review of the device history record showed one nonconforming event which could contribute to this failure mode; the affected unit was identified and scrapped.A review of complaint history showed no other reported complaints for this lot number.Furthermore, reviews of the manufacturer¿s instructions, drawing, and quality control procedures were conducted, and no gaps were discovered.It was thus concluded that there is evidence that all items in the lot in house or in the field are manufactured to specification.The device is packaged with instructions for use, which warn, "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." a previously closed capa determined that forced advancement through restrictive anatomies and failure to reinsert the dilator prior to device removal are both primary contributing factors to sheath separations.Based on the information provided and the examination of the returned product, investigation has concluded that a cause for the device failure could not be established; though patient anatomy, user handling, or the nature of the procedure may have contributed to the device failure.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.
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), specifications, manufacturing instructions, and quality control procedures and a visual inspection of the returned device were conducted during the investigation.One flexor high-flex ansel guiding sheath was returned for investigation.Visual inspection showed biomatter present on the device.The sheath was kinked at 30.8cm from the fitting.The sheath material was separated at 46.9cm from the hub.The separated section measured 8cm.One coil was exposed at the separation site.No other damage was noted.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 one nonconforming event which could contribute to this failure mode; the affected unit was identified and scrapped.A review of complaint history showed no other reported complaints for this lot number.Furthermore, reviews of the manufacturer¿s instructions, drawing, and quality control procedures were conducted, and no gaps were discovered.The device is packaged with instructions for use, which warn, "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 a cause for the device failure could not be established, though patient anatomy, user handling, or the nature of the procedure may have contributed to the device failure.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 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: 9272546
• Report Number: 1820334-2019-02763
• Device Sequence Number: 10796243
• Product Code: DYB
• UDI-Device Identifier: 00827002562363
• UDI-Public: (01)00827002562363(17)220930(10)10050493
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• 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: 09/30/2022
• Device Model Number: G56236
• Device Catalogue Number: KCFW-6.0-35-55-RB-HFANL1-HC
• Device Lot Number: 10050493
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2019
• Initial Date Received by Manufacturer: 10/30/2019
• Supplement Date Received by Manufacturer: 01/24/2020; 03/06/2020
• Initial Report FDA Received Date: 11/04/2019
• Supplement Report FDA Received Date: 01/29/2020; 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 Weight: 81