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

Model Number	N/A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/07/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.
Event or Problem Description
It was reported at the completion of the procedure the physician was removing the sheath that was placed in the leg through the femoral access and it 'separated" and peeled away with about 6" left in the patient.The physician was able to remove all the parts by using a snap to "grab enough of it from the access site to safely remove it without causing any bodily harm." the patients anatomy reportedly "did not appear tortuous or calcified." 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.
Additional Manufacturer Narrative
A review of the complaint history, device history record, documentation, instructions for use ( ifu), quality control, and trends was made.The device was not returned nor images were provided to assist with the investigation.Per qc: the device is fully inspected for any nonconformance.The device history record was reviewed as well and no non-conformances were noted.There is no evidence that the product was not manufactured to specifications.Per ifu: ¿warnings: before withdrawing the sheath through tortuous anatomy, insert the introducer dilator to avoid possible breakage.¿ although the patient did have a pre-existing aneurysm/pseudoaneurysm, the patients anatomy was documented as not appearing tortuous or calcified.Since the device was not returned for evaluation, we were unable to perform visual inspection, dimensional and/or functional testing of the device.Although it is possible the device experienced forces beyond its intended design during removal, without evaluation of the device we cannot conclude with certainty what led to the reported event and customer experience.
Event or Problem Description
The event occurred during an interventional radiology "vascular embolization/occlusion arterial aneurysm or pseudoaneurysm" procedure.
Additional Manufacturer Narrative
Corrected data: date received by mfr date was omitted from follow-up 2 and provided herein.

• Brand Name: FLEXOR SHUTTLE SELECT GUIDING SHEATH
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6159330
• Report Number: 1820334-2016-01505
• Device Sequence Number: 738262
• Product Code: DYB
• UDI-Device Identifier: 00827002311381
• UDI-Public: (01)00827002311381(17)190815(10)7194395
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Radiologic Technologist
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: KSAW-6.0-38-90-RB-SHTL-FLEX-HC
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/14/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided; Not provided
• Initial Report FDA Received Date: 12/09/2016
• Supplement Report FDA Received Date: 05/19/2017; 06/01/2017; 06/01/2017
• 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