MAUDE Adverse Event Report: CODMAN AND SHURTLEFF, INC OG TDL CMPLX FILL COIL 5X15; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	640CF0515
Medical Device Problem Code	Stretched (1601)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/14/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).This initial/final mdr will be the only report submitted for mfr report #1226348-2018-00620.Additional initial reporter information was not provided, but has been requested.(b)(4).Conclusion: it was reported by a healthcare professional that an og cmplx coil (640cf0515/17679484) was unable to be re-sheathed during a procedure.A non-sterile cmplx fill coil 5x15 was received coiled inside of a pouch.The hypo tube was inspected and no damages was noted on it.The introducer was review and was found unzipped.The support coil and the gripper were inspected and no damages were noted on it, while the embolic coil was inspected and was found stuck in the zipper of the introducer and stretched.The functional test cannot be performed due to the embolic coil was inspected and was found stuck and stretched in the zipper of the introducer.A review of the manufacturing documentation associated with lot 17679484 presented no issues during the manufacturing or inspection process that can be related to the reported complaint.The failure reported by the costumer as ¿coil introducer ¿ zipping difficulty re-zipping¿ could not be evaluated the embolic coil was inspected and was found stuck and stretched in the zipper of the introducer.Neither the analysis nor the dhr suggest that the failure reported could be related to the manufacturing process.Procedural factors appear to have contributed to have this failure.There is no current safety signal identified related to the reported event based on review of complaint history for the device.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.
Event or Problem Description
It was reported by a healthcare professional that a coil was unable to be re-sheathed during a procedure.There was no damage noted to the coil or coil detachment system prior to the procedure or upon removal from the patient.There were no kinks or bends noted to the microcatheter that may have contributed to the reported event.No difficulty was encountered while unsheathing the coil.The device was prepped and used according to the instructions for use (ifu).Reportedly, the patient was admitted with sah, severe bleed, and headache.Note: this event was deemed mdr reportable as a result of device evaluation findings.Please see for further details.

• Brand Name: OG TDL CMPLX FILL COIL 5X15
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): CODMAN AND SHURTLEFF, INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 7646610
• Report Number: 1226348-2018-00620
• Device Sequence Number: 19068940
• Product Code: KRD
• UDI-Device Identifier: 10886704030300
• UDI-Public: 10886704030300
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/26/2018

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: No Information
• Device Expiration Date: 04/30/2019
• Device Catalogue Number: 640CF0515
• Device Lot Number: 17679484
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/26/2018
• Initial Report FDA Received Date: 06/28/2018
• Patient Sequence Number: 1
• Patient Age: 53 YR