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

Model Number	N/A
Medical Device Problem Codes	Kinked (1339); Material Separation (1562); Sticking (1597)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	07/17/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has been requested and not yet received.The event is currently under investigation.
Event or Problem 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.
Additional 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.
Additional Manufacturer Narrative
Date received by manufacturer has been corrected to 08/09/2017.
Additional Manufacturer Narrative
(b)(4).

• Brand Name: PERFORMER INTRODUCER
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6785828
• Report Number: 1820334-2017-02492
• Device Sequence Number: 19217501
• Product Code: DYB
• UDI-Device Identifier: 00827002076051
• UDI-Public: (01)00827002076051(17)190812(10)7181041
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/29/2017

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 Model Number: N/A
• Device Catalogue Number: RCF-5.0-35-J
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/17/2017
• Supplement Date Received by Manufacturer: 08/09/2017; 09/13/2017; 11/16/2017
• Initial Report FDA Received Date: 08/10/2017
• Supplement Report FDA Received Date: 08/11/2017; 09/20/2017; 11/29/2017
• 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
• Patient Age: 63 YR
• Patient Weight: 90