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

Catalog Number	KSAW-6.0-38-110-RB-SHTL-HC
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.A supplemental report will be provided upon conclusion.
Event or Problem Description
During a radial artery procedure, the flexor shuttle guiding sheath introducer hydrophilic coating was absent, making its manipulation difficult to handle.It was reported that there was difficulty introducing the device into the radial artery, and the introducer was unable to be withdrawn.The patient's radial artery was dissected and a hematoma was formed; the patient required stitches to close the entrance port.A section of the device did not remain inside the patient¿s body.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Investigation - evaluation: a review of the complaint history, drawings, dimensional verification, device history record, quality control, and visual inspection of the returned device was conducted during the investigation.One used flexor shuttle guiding sheath was returned for investigation.A kink was noted 13.6cm from the proximal end.The presence of coating was confirmed under the fluorescent brightener.The coating was smooth, with adequate coverage and no lifting or separation of coating, and is free from foreign matter.The length of the coating was measured, as well as the entire length of the device, and these measurements lie within specification.A document-based investigation was performed.There is no evidence to suggest the finished product was not made to specifications.Numerous design verification and validation activities have been performed to ensure that this device meets design requirements.The device is 100% inspected for surface imperfections, smooth and adequate coverage and no lifting or separation of coating.A review of the device history record of the finished product shows no nonconforming events that would contribute to this failure mode.There were no other reported complaints for this lot number.It is possible that the coating was not activated properly and/or the technique used to insert and/or withdraw the sheath into the body lead to the resistance experienced by the user which could have potentially lead to damaging the artery.The kink observed near the proximal end of the sheath could also be a result of the difficulty encountered during manipulation of the sheath.However, based on the available information, the examination of the device, and the results of our investigation; a definitive root cause could not be determined.Per the health risk assessment, no further action is required.Appropriate personnel have been notified and 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: 7022936
• Report Number: 1820334-2017-03673
• Device Sequence Number: 1004937
• Product Code: DYB
• UDI-Device Identifier: 00827002501416
• UDI-Public: (01)00827002501416(17)200324(10)7775759
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2018

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 Catalogue Number: KSAW-6.0-38-110-RB-SHTL-HC
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/18/2017
• Supplement Date Received by Manufacturer: 02/06/2018
• Initial Report FDA Received Date: 11/10/2017
• Supplement Report FDA Received Date: 02/06/2018
• 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