MAUDE Adverse Event Report: COOK INC PERFORMER INTRODUCER; DYB INTRODUCER, CATHETER

Model Number N/A

Device Problems Kinked (1339); Material Separation (1562); Sticking (1597)

Patient Problem No Code Available (3191)

Event Date 07/17/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has been requested and not yet received.The event is currently under investigation.

Event Description

A performer introducer was used during an endovenous laser ablation procedure.It was reported that when withdrawing, the j wire, it became stuck just distal to the stop flow end and the floppy tip fell off.A section of the device did not remain inside the patient¿s body.The patient did require additional procedures due to this occurrence, chest x-ray (cxr) and x-ray of the leg at the entry site.The patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

(b)(4).A review of the dimensional verification, complaint history, device history record, manufacturing instructions, quality control, and visual inspection of the returned device was conducted during the investigation.A sheath and wire of a (b)(4) performer introducer set were returned.The floppy tip of the wire is intact.Both welds are present and no separation is noted.The device meets dimensional requirements.There is no evidence to suggest the finished product was not made to specifications.Review of the device history record of the finished product shows no nonconforming events that would contribute to this failure mode.There were no other reported complaints for this lot number.Based on the information provided and the results of our investigation, a definitive root cause could not be determined.Per the quality engineering risk assessment, no further action is warranted.Monitoring will continue to be performed for similar complaints.

Manufacturer Narrative

Date received by manufacturer has been corrected to 08/09/2017.

Manufacturer Narrative

(b)(4).

• Brand Name: PERFORMER INTRODUCER
• Type of Device: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 6785828
• MDR Text Key: 82485452
• Report Number: 1820334-2017-02492
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00827002076051
• UDI-Public: (01)00827002076051(17)190812(10)7181041
• Combination Product (y/n): N
• Reporter Country Code: NZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: RCF-5.0-35-J
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/16/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/12/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR
• Patient Weight: 90