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

Model Number	G29985
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/27/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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, after an angiogram of sfa, angioplasty, and arthrectomy a flexor ansel guiding sheath was being removed when the hub separated from the shaft of the sheath.The angiogram, angioplasty and arthrectomy had all been completed using this sheath prior to removal.After the hub had separated "enough" of the sheath was still intact and outside of the patient, so they were able to remove the rest of the sheath without issue.No portion of the device remained in the patient.This did not result in additional procedures or prolonged hospitalization.The patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Additional information: d10 : product received on.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
The anatomy was not tortuous or calcified.The dilator was not in place when the separation occurred and the sheath and dilator were not removed as a unit.The hub and sheath were held as the device was removed from the patient.Resistance was not reported on insertion or removal of the device.
Event or Problem Description
No new patient or event information to report.
Additional Manufacturer Narrative
Description of event: as reported, after an angiogram of sfa, angioplasty, and arthrectomy a flexor ansel guiding sheath was being removed when the hub separated from the shaft of the sheath.The angiogram, angioplasty and arthrectomy had all been completed using this sheath prior to removal.After the hub had separated "enough" of the sheath was still intact and outside of the patient, so they were able to remove the rest of the sheath without issue.The dilator was not in place when the separation occurred and the sheath and dilator were not removed as a unit.The hub and sheath were held as the device was removed from the patient.Resistance was not reported on insertion or removal of the device.Investigation ¿ evaluation: a visual inspection of the returned device was conducted.A document based investigation was also performed including a review of complaint history, device history record, documentation, drawings, the instructions for use, manufacturing instructions, quality control data, and specifications.One 7fr flexor ansel guiding sheath received used with biomatter present.Inspection found the hub was separated.A review of the device history record found no non-conformances related to the reported failure mode.Because there are no related non-conformances, adequate inspection activities have been established, there is objective evidence that the dhr 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 field.A review of complaint history records shows no other complaints associated with the complaint device lot.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: "warnings -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.Precautions -while inserting, manipulating or withdrawing a device through the sheath, always maintain sheath position.Sheath removal 1.Insert a wire guide until its tip extends at least 10cm past the tip of the sheath.2.Remove the sheath.Avoid applying traction to hub during removal.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.3.Remove the wire guide." a review of relevant manufacturing documents was conducted.It was concluded that the device aspect in question was visually/functionally inspected by quality control and no related gaps in production or processing controls were noted.Based on the evaluation, the cause of this complaint is component failure without design or manufacturing deficiency.Per the quality engineering risk assessment, no further action is warranted.Cook will continue to monitor this device via the complaints database for similar complaints.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.

• Brand Name: FLEXOR ANSEL GUIDING SHEATH
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 10515624
• Report Number: 1820334-2020-01654
• Device Sequence Number: 17033763
• Product Code: DYB
• UDI-Device Identifier: 00827002299856
• UDI-Public: (01)00827002299856(17)230720(10)13315173
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/14/2020

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: 07/20/2023
• Device Model Number: G29985
• Device Catalogue Number: KCFW-7.0-18/38-45-RB-ANL1-HC
• Device Lot Number: 13315173
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2020
• Initial Date Received by Manufacturer: 08/27/2020
• Supplement Date Received by Manufacturer: 09/01/2020; 12/03/2020
• Initial Report FDA Received Date: 09/10/2020
• Supplement Report FDA Received Date: 09/30/2020; 12/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 86