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)
Date of Event	05/31/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Customer name and address= phone: (b)(6); phone: (b)(6).Device evaluated by mfg = other (81) - device evaluation has begun; however, a conclusion is not yet available.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, upon insertion of a flexor introducer sheath during an "afs" procedure, the radiopaque band was noted to be under the hub of the device rather than at the distal end of the sheath.The issue was noticed immediately upon attempted insertion and the user did not continue with the introducer.Reportedly, five devices in total were affected, two used and three unused.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
Description of event: as reported, upon insertion of a flexor introducer sheath during an "afs" procedure, the radiopaque band was noted to be under the hub of the device rather than at the distal end of the sheath.The issue was noticed immediately upon attempted insertion and the user did not continue with the introducer.Reportedly, five devices in total were affected, two used and three unused.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, drawings, the instructions for use, manufacturing instructions, and quality control data.The complainant returned two used, one prior to use, and two unused devices to cook for investigation.Physical examination of the returned devices confirmed no presence of the rb at the distal end of all complaint devices.During tabletop testing, the caps were disassembled from check-flo valves, which showed that the rb was present just below the flares.Per dwg_60049 ((b)(4)) rev035, the radiopaque marker should be 2-3mm from the distal tip of the sheath.Results from the dfa are evidence that the devices were manufactured out of specification.In response to this incident, cook completed a review of the dhr for lot 13861362, which records no relevant non-conformances.A database search for complaints on the reported lot found 11 additional complaints from the field that were reported for the same failure mode ((b)(4)).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 relevant capa, pr218465, was opened 21feb2021 in response to the 3 ksaw-6.0-38-80-rb-shtl-hc devices received for rb in the wrong location (rb located 24-25mm from distal tip instead of 2-3mm).As a part of this capa, quality control implemented a new step to inspect the rbs with a light fixture.The complaint lot was manufactured prior to implementation of the new qc inspection step.With implementation of the new qc inspection step, cook has concluded that sufficient inspection activities are now in place to identify this failure mode prior to distribution.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.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.
Event or Problem Description
No new patient or event information to report.

• 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: 11992336
• Report Number: 1820334-2021-01506
• Device Sequence Number: 847909
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/07/2021

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: 06/10/2021
• Initial Date Received by Manufacturer: 05/31/2021
• Supplement Date Received by Manufacturer: 10/04/2021
• Initial Report FDA Received Date: 06/14/2021
• Supplement Report FDA Received Date: 10/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1