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

Model Number	G09908
Medical Device Problem Code	Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Customer name and address= phone: (b)(6).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 inspection of product stock it was found that the radiopaque band was not visible on six flexor introducer sheaths.There has been no report that any patient experienced adverse effects due to this occurrence.
Additional Manufacturer Narrative
Additional information: 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 was received.Twelve unused devices were affected, not six as originally reported.
Event or Problem Description
Additional information was received on 29jun2021.Thirteen unused devices were affected, not twelve or six as was previously reported.
Additional Manufacturer Narrative
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.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 new patient or event information to report.
Additional Manufacturer Narrative
Description of event: as reported, during inspection of product stock it was found that the radiopaque band was not visible on thirteen flexor introducer sheaths.Investigation ¿ evaluation: a visual inspection and functional testing of the returned unused devices was conducted.A document based investigation was also performed including a review of complaint history, device history record, drawings, the instructions for use, manufacturing instructions, and quality control data.Although the used complaint device was not received, the user facility returned 13 unused devices from the complaint lot to cook for investigation.Physical examination of the returned unused devices confirmed no presence of the radiopaque band at the distal end all complaint devices.During tabletop testing, the caps were disassembled from check-flo valves, which showed that the radiopaque band was present just below the flares.Per the device drawing, the radiopaque marker should be 2-3mm from the distal tip of the sheath.Results from the device failure analysis are evidence that the devices were manufactured out of specification.A review of the device history record found no non-conformances related to the reported failure mode.A database search for complaints on the reported lot found 11 additional complaints from the field that were reported for the same failure mode (reported under manufacturer report # 1820334-2021-01506, 1820334-2021-01515, 1820334-2021-01516, 1820334-2021-01517, 1820334-2021-01518, 1820334-2021-01512, 1820334-2021-01513, 1820334-2021-01514, 1820334-2021-01519, 1820334-2021-01520, and 1820334-2021-01521).At this time, cook concluded that that complaint device is non-conforming and that additional non-conforming product from this lot exists in the field.Cook also reviewed product labeling.The product ifu does not provide information related to the reported failure mode.A device master record (dmr) review was performed, and device drawings, manufacturing instructions, and quality control procedures associated with the complaint were identified.As a new quality control inspection step was implemented via a previously opened capa after the complaint device lot was manufactured, cook has concluded that sufficient inspection activities are now in place to identify this failure mode prior to distribution.Based on the available information, cook has concluded that a manufacturing deficiency contributed to this incident.The investigation determined that two lots were manufactured incorrectly.A recall-removal was initiated for the two affected lots.Investigation into complaint and nonconformance history found no evidence of additional affected lots.The failure mode is highly detectable by end users, and a new inspection step was implemented 01jun2021.The complaint lots were manufactured prior to implementation of the inspection step.The operator responsible for nonconforming devices was retrained to applicable procedures.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 INTRODUCER SHEATH
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 12016904
• Report Number: 1820334-2021-01526
• Device Sequence Number: 11610078
• Product Code: DYB
• UDI-Device Identifier: 00827002099081
• UDI-Public: (01)00827002099081(17)240331(10)13861362
• Combination Product (Y/N): N
• PMA/510(K) Number: K142829
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/06/2021

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: 03/31/2024
• Device Model Number: G09908
• Device Catalogue Number: KCFW-6.0-35-45-RB
• Device Lot Number: 13861362
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2021
• Initial Date Received by Manufacturer: 06/14/2021
• Supplement Date Received by Manufacturer: 06/18/2021; 06/29/2021; 10/04/2021
• Initial Report FDA Received Date: 06/17/2021
• Supplement Report FDA Received Date: 06/22/2021; 06/29/2021; 10/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1