MAUDE Adverse Event Report: CODMAN AND SHURTLEFF, INC (MEXICO) OG TDL CMPLX FILL COIL 6X20; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	640CF0620
Medical Device Problem Code	Stretched (1601)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Information regarding patient age, gender, weight, medical history, race, and ethnicity was not provided.Date of event - the event occurred in 2018; however, the month and date are unknown.Procode: krd/hcg.Initial reporter - the customer contact information, including phone, fax, and e-mail address, was not reported.The product is available for evaluation and testing; however, it has not been received to date (which is indicated as "other").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 a coil embolization procedure, the 6mm x 20cm orbit galaxy tdl complex fill (640cf0620/17697694) hydraulic coil stretched.The physician removed the coil without incident and used another same-sized coil to complete the procedure successfully.No patient complications occurred as a result of the event.The product will be returned for evaluation.It was reported that the information provided for this complaint was all of the details that were known/available regarding this event.
Additional Manufacturer Narrative
(b)(4).As reported by a healthcare professional, the 6mm x 20cm orbit galaxy tdl complex fill (640cf0620/17697694) hydraulic coil stretched during the coil embolization procedure.The physician removed the coil without incident and used another same-sized coil to complete the procedure successfully.No patient complications occurred as a result of the event.Multiple attempts to obtain additional information were unsuccessful.The device was not available for analysis.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.With the limited information available and without the product available for analysis, the reported customer complaint could not be confirmed.Based on the device history record review, there is no indication that the event is related to the manufacturing process of the unit.Stretching of the embolic coil is a known potential failure associated with the use of the device.The instructions for use (ifu) contains several cautions relating to this situation, including instructions for troubleshooting the situation should it be encountered during use.The ifu states the following: ¿visually examine the microcoil for any anomalies such as kinks, burrs, stretched coil, striations, or other damages.If any anomalies are noted or if there is difficulty advancing the microcoil from the introducer sheath, the unit may be defective.Repackage the microcoil and return the entire device for replacement.¿ assignment of root cause for the event remains speculative and inconclusive, based on the minimal information provided; however, it is possible that procedural and handling factors, including device manipulation, may have contributed to the reported failure.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.
Additional Manufacturer Narrative
Product complaint #: (b)(4).The product is available for evaluation and testing; however, it has not been received to date.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.Additional information will be submitted within 30 days of receipt.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.

• Brand Name: OG TDL CMPLX FILL COIL 6X20
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): CODMAN AND SHURTLEFF, INC (MEXICO); circuito interior norte #1820; juarez chihuahua 32580 ; MX 32580
• MDR Report Key: 7981028
• Report Number: 1226348-2018-00757
• Device Sequence Number: 1578343
• Product Code: KRD
• UDI-Device Identifier: 10886704030348
• UDI-Public: 10886704030348
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K093973
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/03/2018

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 Expiration Date: 05/31/2019
• Device Catalogue Number: 640CF0620
• Device Lot Number: 17697694
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/03/2018
• Supplement Date Received by Manufacturer: 10/22/2018; 11/22/2018
• Initial Report FDA Received Date: 10/18/2018
• Supplement Report FDA Received Date: 10/31/2018; 12/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1