MAUDE Adverse Event Report: CODMAN AND SHURTLEFF, INC TRUFILL DCS SYRINGE II; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	635-002
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/09/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, age, gender, weight, race, ethnicity, and medical history were not provided.The name, phone and email address of the initial reporter are not available / reported.The device is available to be returned for evaluation and testing.However, it has not been received to date as indicated as ¿other¿ in this section as the reason for non-evaluation.If the device returns, a device investigation will be performed.A review of manufacturing documentation associated with this lot (96331354) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformance's related to device manufacture or inspection.All product rejected during manufacturing was identified as scrap and properly accounted for.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.This is one of two products involved with the reported complaint.The associated manufacturer report numbers are: 1226348-2020-00457.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 manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.
Event or Problem Description
The healthcare professional reported that during the procedure, the physician felt water leaking during the attempt to detach the coil using the trufill dcs syringe ii (635002 / 96331354).The physician replaced it with another trufill dcs syringe ii, and the procedure was successfully completed.There was no report of any patient adverse event or complications.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to report that the complaint product is no longer available for return.[conclusion]: the healthcare professional reported that during the procedure, the physician felt water leaking during the attempt to detach the coil using the trufill dcs syringe ii (635002 / 96331354).The physician replaced it with another trufill dcs syringe ii, and the procedure was successfully completed.There was no report of any patient adverse event or complications.Multiple attempts to obtain additional information related to the procedure, the reported device issue and to obtain the product for analysis were unsuccessful.If additional information is available at a later date and the product is returned, the file will be updated accordingly.Based on complaint information, the device was not available to be returned for analysis.A review of manufacturing documentation associated with this lot (96331354) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformances related to device manufacture or inspection.All product rejected during manufacturing was identified as scrap and properly accounted for.Product analysis cannot be conducted as the product was not returned for analysis.No determination of causes and possible contributing factors could be made.As such, the investigation will be closed.The reported issue that the trufill dcs syringe ii was leaking during the attempt to detach the coil.With the limited information available and without the product and concomitant microcatheter available for analysis, the reported customer complaint cannot be confirmed.Based on the manufacturing documentation review, there is no indication that the event is related to the device manufacturing process.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.This is one of two products involved with the reported complaint.The associated manufacturer report numbers are: 1226348-2020-00456 and 1226348-2020-00457.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.

• Brand Name: TRUFILL DCS SYRINGE II
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): CODMAN AND SHURTLEFF, INC; 325 paramount dr; raynham MA 02767
• MDR Report Key: 10471961
• Report Number: 1226348-2020-00456
• Device Sequence Number: 14039477
• Product Code: HCG
• UDI-Device Identifier: 10886704029410
• UDI-Public: 10886704029410
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K063254
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/09/2020

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: 01/31/2022
• Device Model Number: 635-002
• Device Catalogue Number: 635002
• Device Lot Number: 96331354
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/09/2020
• Supplement Date Received by Manufacturer: 09/17/2020
• Initial Report FDA Received Date: 08/31/2020
• Supplement Report FDA Received Date: 09/25/2020
• 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: TRUFILL DCS SYRINGE II; TRUFILL DCS SYRINGE II