MAUDE Adverse Event Report: COOK INC PEEL-AWAY DENNY SHEATH INTRODUCER SET; DYB INTRODUCER, CATHETER

Model Number	N/A
Medical Device Problem Codes	Collapse (1099); Material Frayed (1262)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/28/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Occupation: unknown.Pma/510(k) #: pre-amendment.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.
Event or Problem Description
It was reported a peel-away denny sheath introducer set was used for placement of a peripherally inserted central catheter in the inner portion of the upper arm of the patient (no anomalies/previous scarring).The physician accessed the vessel with ultrasound guidance and successfully advanced the wire.Upon attempting to advance the denny sheath, the product buckled and the tip of the sheath was found to have frayed.This happened a total of five times with different denny sheaths each time.A sixth denny sheath was used successfully and although prolonged, the procedure was completed.This report records two of the five sheaths.The other three sheaths have different or unknown lot numbers and are recorded under medwatch report # 1820334-2018-03343 and 1820334-2018-03390.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.Additional information regarding patient demographics and pre-existing conditions has been requested but is unavailable at this time.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.The event is currently under investigation.A follow-up report will be submitted upon receipt of additional information or completion of the investigation.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
Event or Problem Description
It was originally reported that one device was used during the procedure.It was found during preliminary analysis on (b)(6) 2018 that two used devices were returned for evaluation.It is assumed that both devices are from the same lot 9042946.

• Brand Name: PEEL-AWAY DENNY SHEATH INTRODUCER SET
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8061200
• Report Number: 1820334-2018-03344
• Device Sequence Number: 16863739
• Product Code: DYB
• UDI-Device Identifier: 00827002115644
• UDI-Public: (01)00827002115644(17)210724(10)9042946
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/17/2018

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/24/2021
• Device Model Number: N/A
• Device Catalogue Number: PLIP-3.5-18-9-DENNY
• Device Lot Number: 9042946
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2018
• Initial Date Received by Manufacturer: 10/29/2018
• Supplement Date Received by Manufacturer: 11/19/2018
• Initial Report FDA Received Date: 11/12/2018
• Supplement Report FDA Received Date: 12/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1