MAUDE Adverse Event Report: CODMAN AND SHURTLEFF, INC ORBIT COMPLEX FILL 5X15 TDL; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number 638CF0515

Device Problems Premature Activation (1484); Stretched (1601); Material Twisted/Bent (2981)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/28/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Information regarding patient identifier, date of birth, age, gender, weight, race, ethnicity, and medical history were not provided.Initial reporter information such as the name, phone and email address are not available / unknown.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 (30003280) 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.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 Description

The healthcare professional reported that during the coil embolization procedure of 8.2 mm x 6.8 mm irregular aneurysm on the left anterior communicating artery, the 5 mm x 15 cm trufill orbit complex fill coil (638cf0515 / 30003280) was selected for the dense embolization procedure.The product was checked and found to be normal before it was use.The physician reported that the coil could not advance further when it passed 1/3 of the target lesion.The coil was removed and found to be stretched.The procedure was completed with a replacement coil that is the same as the orbit complex fill coil.It was reported that the event did not result in the loss of cerebral target position.There was no report of patient complications as a result of the reported event.The procedure was conducted in accordance with the instructions for use (ifu) with constant flush maintained at all time.There was no visible defect or damage noted on the product prior to the event.The product is available to be returned for evaluation.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr is to include the additional event information received on 04/07/2019.[additional information]: the healthcare professional reported that during the coil embolization procedure of 8.2 mm x 6.8 mm irregular aneurysm on the left anterior communicating artery, the 5 mm x 15 cm trufill orbit complex fill coil (638cf0515 / 30003280) was selected for the dense embolization procedure.The product was checked and found to be normal before it was use.The physician reported that the coil could not advance further when it passed 1/3 of the target lesion.The coil was removed and found to be stretched; no other damage was noted on the coil when it was removed.It was reported that the coil was stretched and then it was prematurely detached.The procedure was completed with a replacement coil that is the same as the orbit complex fill coil.It was reported that the event did not result in the loss of cerebral target position.There was no kink on the microcatheter that could have contributed to the reported event.There was no report of patient complications as a result of the reported event.The procedure was conducted in accordance with the instructions for use (ifu) with constant flush maintained at all time.There was no visible defect or damage noted on the product prior to the event.The product is available to be returned for evaluation.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.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to report the investigational finding of the returned device.[conclusion]: the healthcare professional reported that during the coil embolization procedure of 8.2 mm x 6.8 mm irregular aneurysm on the left anterior communicating artery, the 5 mm x 15 cm trufill orbit complex fill coil (638cf0515 / 30003280) was selected for the dense embolization procedure.The product was checked and found to be normal before it was use.The physician reported that the coil could not advance further when it passed 1/3 of the target lesion.The coil was removed and found to be stretched; no other damage was noted on the coil when it was removed.It was reported that the coil was stretched and then it was prematurely detached.The procedure was completed with a replacement coil that is the same as the orbit complex fill coil.It was reported that the event did not result in the loss of cerebral target position.There was no kink on the microcatheter that could have contributed to the reported event.There was no report of patient complications as a result of the reported event.The procedure was conducted in accordance with the instructions for use (ifu) with constant flush maintained at all time.There was no visible defect or damage noted on the product prior to the event.The product was received for evaluation and analysis.The investigational finding is documented below.Investigation summary: the non-sterile 5 mm x 15 cm trufill orbit complex fill coil was received contained in a pouch.The returned device underwent visual inspection.The hypotube was inspected and was observed kinked at 34 cm, 59 cm, and 90 cm from the proximal end.The coil introducer was unzipped but there was no appearance of damage observed on the component.The returned device underwent dimensional measurements.The outer diameter (od) of the delivery tube was measured and was found within specification.The actual hypotube od was 0.0128 inch; specification: 0.0130 inch (+0.000 / -0.0005).The actual body fusion od was 0.01401 inch; specification: max od 0.0156 inch.The support coil od 0.0138 inch; specification: max od 0.0156 inch.The distal fusion od 0.0150 inch; specification: max od 0.0156 inch.Microscopic inspect was performed.The support coil was outside of the introducer but was observed without any damage.The gripper was in good condition.The embolic coil was in stretched, tangled condition with kinks observed.The condition of the kinked hypotube and the stretched, tangled, and kinked condition of the embolic coil precluded the device from functional testing.A review of manufacturing documentation associated with this lot (30003280) 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.The reported issue that the coil was stretched was confirmed with the microscopic inspection of the embolic coil.The issue related to the coil not being impeded and not able to advance could not be confirmed through functional testing due to the condition of the returned device.As with the reported premature detachment of the coil; the condition of the coil precluded it from undergoing functional testing.The kinked hypotube and the condition of the embolic coil being kinked and stretched suggest that force during the handling of the device may have been excessive, though the exact cause cannot be conclusively determined.Coil kinked and stretched are known potential issues associated with the use of the device.The instruction for use provides proper handling instructions for the device to prevent issues such as kink and stretching from occurring.The reported issue related to the coil not being able to advance further when it passed 1/3 of the target lesion which prompted the removal of the coil may have contributed to the coil becoming kinked, stretched and ultimately prematurely detached due to the handling of the device during the removal attempt.The exact cause cannot be conclusively determined, however, the kinks observed on the hypotube and the condition of the embolic coil suggest that force may have been inadvertently applied during the device handling/manipulation.Based on the device history record review, there is no indication that the event is related to the device manufacturing process.In addition, devices undergo 100% inspection at final assembly for the condition of the embolic coil.Thus, it is not likely that the 5 mm x 15 cm trufill orbit complex fill coil left the manufacturing facility with the embolic coil kinked and in a stretched condition as was observed on the embolic coil of the returned device.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.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to make a correction to the manufacturer information in to report that the product was received by the product analysis lab on 5/9/2019.The return product is pending evaluation.A supplemental 3500a report will be submitted once the product investigation has been completed.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: ORBIT COMPLEX FILL 5X15 TDL
• Type of Device: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): CODMAN AND SHURTLEFF, INC; 325 paramount dr; raynham MA 02767
• MDR Report Key: 8457399
• MDR Text Key: 140150118
• Report Number: 1226348-2019-00845
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 10886704029991
• UDI-Public: 10886704029991
• Combination Product (y/n): N
• PMA/PMN Number: K053197
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2019
• Device Catalogue Number: 638CF0515
• Device Lot Number: 30003280
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2019
• Date Manufacturer Received: 06/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1