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

Catalog Number	KSAW-6.0-38-110-RB-SHTL-HC
Health Effect - Clinical Code	No Information (3190)
Date of Event	04/28/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This mdr is being filed after the associated complaint was reviewed under remediation protocol (b)(4), complaint/mdr retrospective review and remediation and reassessed as reportable.Additional complaint investigation and record remediation was not performed.
Event or Problem Description
While preparing material to perform left external and primitive angioplasties with stent(s), the doctor tried to place the dilator inside the sheath.However, the doctor couldn't progress to the end of the sheath and was also unable to "clip" the dilator on the valve of the sheath.The doctor noticed that the dilator extremity was covered by a "strange sticky substance," which looked like glue.He supposed it was inside the sheath and the dilator was covered with the substance upon passing through the sheath.As a result, he was given a different device with the same part and lot number in which he noted presented the same problem- no ability to join the dilator and sheath together to assemble the introducer and a strange sticky substance on the sheath which came out during the attempt to place the dilator inside the sheath.The complainant reported that there was adverse effects on the patient as a result of this product problem.However, this product problem occurred prior to patient contact and no adverse effects were specified.

• 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: 6590430
• Report Number: 1820334-2017-01168
• Device Sequence Number: 395528
• Product Code: DYB
• UDI-Device Identifier: 00827002501416
• UDI-Public: (01)00827002501416(17)181109(10)6364082
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/25/2017

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: KSAW-6.0-38-110-RB-SHTL-HC
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/25/2017
• Initial Report FDA Received Date: 05/25/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Weight: 80