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

Model Number	G28438
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/27/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pma/510(k) number = preamendment (b)(4).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 that during an inferior vena cava (ivc) filter retrieval, the haemostatic valve of the performer introducer fell off.Another performer introducer was utilized to successfully complete the procedure with no further issues.A section of the device did not remain inside the patient¿s body.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Investigation ¿ evaluation: a review of the complaint history, device history record, quality control, and a visual inspection of the returned device were conducted during the investigation.The visual inspection of the returned device confirmed that the silicone disc of the device was dislodged.The check-flo cap was removed to obtain the silicone disc.The top and bottom slits on the disk were not cut edge to edge, and the bottom slit had a 5mm tear that was perpendicular to slit.Additionally, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.A review of the device history record showed no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.Based on the information provided, the examination of the returned product, and the results of our investigation, a definitive root cause could not be determined.We will continue to monitor for similar complaints.Per the quality engineering risk assessment, no further action is required.
Additional Manufacturer Narrative
Narrative: per additional information received on 01mar2018, the haemostatic valve of the performer introducer fell off prior to any attempt at retrieving the inferior vena cava (ivc) filter.The patient's jugular vein was punctured, and the separation was observed as soon as the introducer was inserted over the wire guide to advance into the vein.The in-situ filter (another manufacturer's option elite ivc filter) was successfully retrieved using another performer introducer.This report includes information known at this time. a follow-up report will be submitted should additional relevant information become available.

• Brand Name: PERFORMER INTRODUCER
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK VASCULAR INC; 1186 montgomery lane; vandergrift PA 15690
• MDR Report Key: 7305799
• Report Number: 1820334-2018-00636
• Device Sequence Number: 2379425
• Product Code: DYB
• UDI-Device Identifier: 00827002284388
• UDI-Public: (01)00827002284388(17)200414(10)NS7786627
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/22/2018

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 Model Number: G28438
• Device Catalogue Number: RCFW-14.0-38-45-RB
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 02/27/2018
• Supplement Date Received by Manufacturer: 03/01/2018; 05/04/2018
• Initial Report FDA Received Date: 03/01/2018
• Supplement Report FDA Received Date: 03/08/2018; 05/22/2018
• 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: ARGON MEDICAL DEVICES OPTION ELITE IVC FILTER