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

Catalog Number	KCFW-6.0-38-40-RB-BLKN-HC
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/21/2016
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
During the percutaneous transluminal angioplasty (pta) procedure, upon attempting to insert the introducer into the body of the patient, the tip of the introducer was noted to be irregular/damaged and as a result, could not be advanced.Additionally, device imaging identified the tip of the sheath is split.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.

• Brand Name: FLEXOR BALKIN GUIDING SHEATH
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6567072
• Report Number: 1820334-2017-01161
• Device Sequence Number: 106189
• Product Code: DYB
• UDI-Device Identifier: 00827002322240
• UDI-Public: (01)00827002322240(17)181125(10)6409158
• Combination Product (Y/N): N
• 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): 05/15/2017

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: KCFW-6.0-38-40-RB-BLKN-HC
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/10/2017
• Initial Report FDA Received Date: 05/15/2017
• 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: AMLRTZ STIFF 0,035 DRAHT
• Patient Age: 66 YR
• Patient Weight: 59