MAUDE Adverse Event Report: CODMAN AND SHURTLEFF, INC TRUFILL COIL PUSHER, DUAL MARK; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	632-774X
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/15/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Initial reporter: the customer contact information was not provided.Information regarding patient age, gender, weight, race, ethnicity, and medical history were not provided.The product has been returned for evaluation and testing; however, the engineering evaluation has not been completed.Additional information will be submitted within 30 days of receipt.Missing information from this report is identified as blank; this information was not provided in the reported event or available at the time of report submission.The company is seeking this information through the event investigation.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.
Event or Problem Description
As reported by a healthcare professional, during the procedure, a trufill coil pusher ((b)(4)) became frayed 20 centimeters (cm) from the tip and could no longer be used.The product was subsequently replaced with a competitor product.The procedure was completed successfully without further issues or delay.There was no report of consequence or impact to the patient.The product was new and stored per labeling instructions.The procedure was conducted in accordance with the instructions for use (ifu) and a constant flush was maintained.No visible product damage was observed prior to the event.The product was returned for analysis.Procedural and patient details are unknown.No further information was provided.
Additional Manufacturer Narrative
Product complaint # (b)(4).Additional information received indicated that the product neither fractured nor separated into two or more pieces.The reported issue did not result in a procedural delay.No further information could be obtained.Complaint conclusion: as reported by a healthcare professional, the trufill coil pusher (632774x/10848582) became frayed 20 centimeters (cm) from the tip and could no longer be used.The product was subsequently replaced with a competitor product.The procedure was completed successfully without further issues or delay.There was no report of consequence or impact to the patient.The product was new and stored per labeling instructions.The procedure was conducted in accordance with the instructions for use (ifu) and a constant flush was maintained.No visible product damage was observed prior to the event.Additional information received indicated that the product neither fractured nor separated into two or more pieces.The event did not result in a procedural delay.No further information was provided.A non-sterile trufill coil pusher, dual mark was received coiled in a plastic bag.The wire was inspected and found stretched.Residues of dried saline solution were also observed.The ptfe presented evidence of elongation scratches.The ptfe was peeled from the guide wire.No other anomalies were detected during analysis.The core wire was inspected under microscope and it was found stretched.A review of the manufacturing documentation associated with this lot presented no issues during the manufacturing or inspection process that can be related to the reported complaint.The reported customer complaint was confirmed during analysis of the returned product.The stretched condition and ptfe elongation may have been caused the application of excessive force; however, the exact cause could not be conclusively determined.Based on the information provided, there were device handling/procedural factors that may have contributed to the reported event.As part of the post market surveillance program, information from this complaint is trended for statistical signals and corrective/preventive action may be triggered at a later time.Since there was no evidence to suggest the event was related to a manufacturing or design issue, no corrective actions will be taken at this time.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.

• Brand Name: TRUFILL COIL PUSHER, DUAL MARK
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): CODMAN AND SHURTLEFF, INC; 325 paramount dr; raynham MA 02767
• MDR Report Key: 7170190
• Report Number: 1226348-2018-00503
• Device Sequence Number: 1823698
• Product Code: HCG
• UDI-Device Identifier: 10886704029168
• UDI-Public: (01)10886704029168(17)200501(10)10848582
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K983483
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/15/2017

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/01/2020
• Device Model Number: 632-774X
• Device Catalogue Number: 632774X
• Device Lot Number: 10848582
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2018
• Initial Date Received by Manufacturer: 12/14/2017
• Supplement Date Received by Manufacturer: 02/08/2018
• Initial Report FDA Received Date: 01/05/2018
• Supplement Report FDA Received Date: 02/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1