MAUDE Adverse Event Report: CODMAN AND SHURTLEFF, INC OG TDL CMPLX FILL COIL 8X24; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	640CF0824
Medical Device Problem Code	Stretched (1601)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/21/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, weight, race, ethnicity, and medical history were not provided.Procode is krd/hcg.Lot #: the device lot number is not available / not reported.The expiration date of the device is not known.Reporter: the name, phone and email address of the initial reporter are not available / reported.Device evaluated by mfr: 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.Manufacture date: the device manufacture date is not known as the device lot number is not available / not reported.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 8mm x 24cm orbit galaxy complex fill coil (640cf0824 / lot# unknown) could not be advanced nor retrieved by the physician.The physician removed the coil and the microcatheter (unknown brand)at the same time and after inspecting the coil, it was observed to be stretched.Another orbit galaxy complex fill coil was used, and the procedure was successfully completed.There was no report of any patient injury or complication with the reported event.It was reported that the device is available to be returned for evaluation and analysis.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to report that multiple attempts have been made to obtain additional information and to obtain the product for analysis were unsuccessful; the product investigation will be closed as no further investigation can be performed at this time.If the product is returned or additional information is provided at a later date, the file will be updated and a supplemental 3500a report will be submitted.[conclusion]: the healthcare professional reported that during the procedure, the 8mm x 24cm orbit galaxy complex fill coil (640cf0824 / lot# unknown) could not be advanced nor retrieved by the physician.The physician removed the coil and the microcatheter (unknown brand) at the same time and after inspecting the coil, it was observed to be stretched.Another orbit galaxy complex fill coil was used, and the procedure was successfully completed.There was no report of any patient injury or complication with the reported event.It was reported that the device is available to be returned for evaluation and analysis, however, multiple attempts were made to obtain additional information related to the device, the procedure and to obtain the product for analysis were unsuccessful.The device has not been returned for analysis and therefore, no further investigation can be performed at this time.The device lot number was not available.The device history record (dhr) review could not be performed without the lot number.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.Coil stretching is a known potential issue associated with the use of this device.The instruction for use (ifu) provides proper handling instructions for the device to prevent such issue from occurring.With the limited information available and without the product available for analysis, the reported customer complaint could not be confirmed.The lot number of the device is not known, therefore review of the device history record was not performed.Assignment of root cause for the event remains speculative and inconclusive, based on the limited information provided and without the return of the complaint device; however, it is possible that clinical and procedural factors, including device manipulation / interaction, aneurysm size vessel characteristics, device selection, and the concomitant microcatheter, 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.Additional information will be submitted within 30 days of receipt.

• Brand Name: OG TDL CMPLX FILL COIL 8X24
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): CODMAN AND SHURTLEFF, INC; 325 paramount dr; raynham MA 02767
• MDR Report Key: 8515435
• Report Number: 1226348-2019-00876
• Device Sequence Number: 1928456
• Product Code: KRD
• UDI-Device Identifier: 10886704030386
• UDI-Public: 10886704030386
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2019

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 Catalogue Number: 640CF0824
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/25/2019
• Supplement Date Received by Manufacturer: 06/13/2019
• Initial Report FDA Received Date: 04/15/2019
• Supplement Report FDA Received Date: 06/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1