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

Model Number	N/A
Medical Device Problem Code	Difficult or Delayed Positioning (1157)
Health Effect - Clinical Code	Pain (1994)
Date of Event	01/10/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Evaluation- a review of dimensional verification functional testing, device history record, instructions for use, quality control and a visual inspection of the returned device was conducted for the purpose of this investigation.One used flexor shuttle guiding sheath (without an attached tuohy-borst) was returned for investigation with biomatter present (subject of this report).No apparent damage was observed on the sheath tubing.The same functional test that was performed with the three unopened, unused devices was also performed with the returned complaint device.The complaint device did not feel as lubricious as the sealed unused devices obtained for testing.However, hydrophilic coating was still present and able to be activated.The used condition of the complaint device may have affected the lubricity of the coating.Also, the length of the coated portion on the complaint device was measured and confirmed to be within specifications.Instructions for use are attached to each sealed packaged device.The ifu sent with the device states, "precautions: do not attempt to insert or withdraw the wire guide and/or introducer if resistance is felt.Sheath introduction: if using an introducer with aq hydrophilic coating, activate hydrophilic coating by wetting the outer surface of the device with heparinized saline.Note: for best results, maintain wetted condition of device during placement." a device history search found there was no evidence to suggest the device was not manufactured according to specifications.It is possible that the difficult insertion could have been caused by the complaint device not being activated properly before insertion.However, it was reported that "the cardiologists wet the introducer, but it did not slide inside." there have been complaints reported on sheaths for difficult advancement due to the sheath tip not being able to maintain a smooth transition between the sheath and dilator.The dilator was not returned with the complaint device, so we could not inspect for a smooth transition.However, no damage was found to the sheath tip of the returned complaint device, so it is unlikely that an unsmooth transition would have caused the difficult insertion.Based on the available information and without being able to replicate the reported failure, a root cause could not be determined.
Event or Problem Description
It was alleged that the introducer device was missing the hydrophilic coating during three separate procedures.The reporter stated that the ¿cardiologists wet the introducer and it did not slide inside.¿ the incident reportedly resulted: no harm or consequence to the patient.(1820334-2017-00128).In a complication causing the patient pain and the need for antalgic medicine.(1820334-2017-00123).Inability to advance the device.It was not reported how the procedure was completed.(1820334-2017-00124).Additional information has been requested but not provided at the time of this report.
Additional Manufacturer Narrative
(b)(4).Evaluation narrative: a review of dimensional verification, functional testing, device history record, complaint history, instructions for use (ifu), drawing, quality control, and a visual inspection of the returned device was conducted for the purpose of this investigation there were two other similar reported complaints for this lot number.Review of the device history record shows no nonconforming events that would contribute to this failure mode.One used flexor shuttle guiding sheath (without an attached tuohy-borst) was returned for investigation with biomatter present.No apparent damage was observed on the sheath tubing.The same functional test that was performed with the three unopened, unused devices was also performed with the returned complaint device.The complaint device did not feel as lubricious as the sealed unused devices obtained for testing.However, hydrophilic coating was still present and able to be activated.The used condition of the complaint device may have affected the lubricity of the coating.Also, the length of the coated portion on the complaint device was measured and confirmed to be within specifications.Instructions for use are attached to each sealed packaged device.The ifu sent with the device state: "precautions: do not attempt to insert or withdraw the wire guide and/or introducer if resistance is felt.¿ ¿sheath introduction: if using an introducer with aq hydrophilic coating, activate hydrophilic coating by wetting the outer surface of the device with heparinized saline.Note: for best results, maintain wetted condition of device during placement." while the label does not specifically state that the device is hydrophilic coated, the hc suffix in the product number stands for ¿hydrophilic coated¿ it is possible that the difficult insertion could have been caused by the complaint device not being activated properly before insertion.However, it was reported that "the cardiologists wet the introducer, but it did not slide inside." there have been complaints reported on sheaths for difficult advancement due to the sheath tip not being able to maintain a smooth transition between the sheath and dilator.The dilator was not returned with the complaint device, so we could not inspect for a smooth transition.However, no damage was found to the sheath tip of the returned complaint device, so it is unlikely that an unsmooth transition would have caused the difficult insertion.Based on the available information and without being able to replicate the reported failure, a root cause could not be determined.The device has been archived at the manufacturing facility.Per the quality engineering risk assessment, no further action is warranted.Monitoring will continue to be performed for similar complaints.

• Brand Name: FLEXOR SHUTTLE GUIDING SHEATH
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6297027
• Report Number: 1820334-2017-00123
• Device Sequence Number: 16336928
• Product Code: DYB
• UDI-Device Identifier: 00827002501416
• UDI-Public: (01)00827002501416(17)191021(10)7377179
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/11/2017

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: KSAW-6.0-38-110-RB-SHTL-HC
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/10/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/02/2017
• Supplement Report FDA Received Date: 05/11/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention