MAUDE Adverse Event Report: COOK INC FLEXOR HIGH-FLEX ANSEL GUIDING SHEATH; DYB INTRODUCER, CATHETER

Catalog Number	KCFW-8.0-35-110-RB-HFANL1-HC
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	06/30/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).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
The complainant reported that it was impossible to advance another manufacturer's paravalvular leak device (pld) devices with size 7 fr and 8 fr due to a very tight hemostatic valve.This product problem, which occurred during closure of a paravalvular leak in the aortic valve, led to a delay in completing the procedure and increased blood loss.Eventually, the hemostatic valve was completely removed and the pld devices were advanced through the sheath.Hemostasis was partially achieved manually.

• Brand Name: FLEXOR HIGH-FLEX ANSEL GUIDING SHEATH
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6561683
• Report Number: 1820334-2017-01143
• Device Sequence Number: 18852921
• Product Code: DYB
• UDI-Device Identifier: 00827002490468
• UDI-Public: (01)00827002490468(17)180416(10)5810215
• Combination Product (Y/N): N
• Initial Reporter Country: CY
• 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): 05/11/2017

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 Catalogue Number: KCFW-8.0-35-110-RB-HFANL1-HC
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/10/2017
• Initial 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
• Concomitant Medical Products and Therapy/Usage Dates: OCCLUTECH PARAVALVULAR LEAK DEVICE (PLD)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 85