MAUDE Adverse Event Report: CODMAN AND SHURTLEFF, INC OG TDL CMPLX FRAME COIL 8X30; ORBIT GALAXY

Catalog Number	640CR0830
Medical Device Problem Codes	Positioning Problem (3009); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/12/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Procode: krd/hcg.The device is available to be returned for evaluation and testing.However, it has not been received to date.If the device returns, a device investigation will be performed.A supplemental report will be submitted 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, an 8x30 og tdl cmplx frame coil was being used as the first coil but could not be shaped as expected.The surgeon withdrew the coil for re-position.But then the coil could not be pushed into the aneurysm.The surgeon used another coil to complete the procedure.There was no report of patient injury.The device will be returned for analysis.
Additional Manufacturer Narrative
Product complaint (b)(4).Complaint conclusion: as reported by a healthcare professional, during a coil embolization, an 8x30 og tdl cmplx frame coil was being used as the first coil but could not be shaped as expected.The surgeon withdrew the coil for re-position.But then the coil could not be pushed into the aneurysm.The surgeon used another coil to complete the procedure.There was no report of patient injury.No additional information is available.A non-sterile og tdl cmplx frame coil 8x30 was received coiled inside of a pouch.The hub was inspected, and no damages were noted on it.The hypo tube was inspected, and it was found several kinked.The introducer was not received for evaluation.The gripper was inspected, and it was found several kinked.The support coil and embolic coil were inspected under microscope and no damages were noted on them.A manufacturing record evaluation was performed for the finished device 30117267 number, and no non-conformances related to the reported complaint condition were identified.The failure reported by the customer as ¿coil¿ impeded-in delivery catheter with no loss of cerebral target position¿ could not be evaluated due to introducer was not received with the device.The failure reported by the customer as ¿coil ¿ positioning difficulty-poor conformability¿ could not be evaluated because it is specific to the patient and procedure at the time of occurrence and cannot be replicated in the lab.The kinked condition noted on the device appears to have been caused by excessive force being applied to the device.Neither the product analysis nor the mre review suggests that the failure could be related to the manufacturing process.Based on the limited information available for review, it is possible that clinical and procedural factors, including device manipulation / interaction, aneurysm size and vessel characteristics, device selection, and the concomitant microcatheter, may have contributed to the reported issues.The instructions for use (ifu) states that continuous infusion of an appropriate flush solution is required for optimal performance, and also indicates that the flush should be verified in the event of resistance.Insufficient flush allows blood to back-flow into the microcatheter, which can cause resistance.The ifu instructs on proper positioning of the microcoil system.The ifu also warns: ¿if repositioning of the microcoil is necessary, carefully observe the motion of the microcoil in respect to the dpu wire while retracting the microcoil under fluoroscopy.If the microcoil movement is not one-to-one with the dpu wire, or if repositioning is difficult, the microcoil may have become stretched and could possibly break.Gently remove and discard the microcoil system¿.As part of the post market surveillance program, information from this complaint is trended to identify statistical signals for consideration of further correction action.Since there was no evidence to suggest the events were related to a manufacturing or design issue, no corrective actions will be taken at this time.

• Brand Name: OG TDL CMPLX FRAME COIL 8X30
• Common Device Name: ORBIT GALAXY
• Manufacturer (Section D): CODMAN AND SHURTLEFF, INC; 325 paramount dr; raynham MA 02767
• MDR Report Key: 8799140
• Report Number: 1226348-2019-00955
• Device Sequence Number: 11383903
• Product Code: KRD
• UDI-Device Identifier: 10886704030454
• UDI-Public: 10886704030454
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K093973
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2019

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 Expiration Date: 07/31/2020
• Device Catalogue Number: 640CR0830
• Device Lot Number: 30117267
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2019
• Initial Date Received by Manufacturer: 06/25/2019
• Supplement Date Received by Manufacturer: 08/21/2019
• Initial Report FDA Received Date: 07/17/2019
• Supplement Report FDA Received Date: 09/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1