MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL G2 COMPLEX XTRASOFT COIL 2.5X3; ORBIT GALAXY ENPOWER XTRASOFT

Catalog Number	641CX2535
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/26/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint #: (b)(4).Procode: krd/hcg.Initial reporter: the customer contact information, including name, occupation, phone, fax, and e-mail address, was not reported.Manufacturing site name: codman and shurtleff inc., dba depuy synthes products, inc.(b)(4).The device is available to be returned for evaluation and testing.However, it has not been received to date.F the device returns, a device investigation will be performed.Information regarding patient weight, height, medical history, race, and ethnicity was not reported.The company is seeking this information through the event investigation.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 an affiliate, during a coil embolization, a g2 complex xtrasoft coil (641cx2535, unknown lot) broke from the fiber loop and auto detach before detachment system complete.The device was removed from the microcatheter.The surgery was delayed by 10 minutes due to the reported event.The procedure was successfully completed.There was no patient injury reported.
Additional Manufacturer Narrative
Product complaint #: (b)(4).A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.Complaint conclusion: as reported by an affiliate, during a coil embolization, a g2 complex xtrasoft coil (641cx2535, unknown lot) broke from the fiber loop and auto detach before detachment system complete.The device was removed from the microcatheter.The surgery was delayed by 10 minutes due to the reported event.The procedure was successfully completed.There was no patient injury reported.Multiple attempts to obtain additional information were unsuccessful.The device has not been returned for analysis and therefore no further investigation can be performed at this time.The manufacturing record evaluation (mre) cannot be performed due to the lot number was not provided.With the information available and without the product available for analysis, the reported customer complaint of ¿coil - premature detachment¿ could not be confirmed.Without a lot number, the mre was not ale to be completed.The exact cause of the event could not be determined; however, there are circumstances of the procedure that may have contributed to the reported failure.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 event was related to a manufacturing or design issue, no corrective actions will be taken at this time.
Additional Manufacturer Narrative
Product complaint # (b)(4).A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.Complaint conclusion updated with product analysis: as reported by an affiliate, during a coil embolization, a g2 complex xtrasoft coil (641cx2535, unknown lot) broke from the fiber loop and auto detach before detachment system complete.The device was removed from the microcatheter.The surgery was delayed by 10 minutes due to the reported event.The procedure was successfully completed.There was no patient injury reported.Multiple attempts to obtain additional information were unsuccessful.One non-sterile unit g2 complex xtrasoft coil 2.5x3 was received inside of a pouch.The hub, the dpu, the introducer and the re-sheathing tool were inspected, and no damages were noted on them.Also, the introducer was found zipped.The v-notch was inspected under microscope and no damages were noted on it.The rh was inspected under microscope and it was found in good conditions.Rh was no heated.The embolic coil was inspected under microscope and it was found still attached to the rh and no damages were observed on it.The manufacturing record evaluation (mre) cannot be performed due to the lot number was not provided.The complaint reported by the customer ¿coil- premature detachment¿ was not able to confirm due the distal outer sheath had not been softened indicating that the resistance heating coil had not been heated and the detachment process was not initiated also the embolic coil was found still attached to the rh.Based on the limited information provided, it is possible that clinical and procedural factors could have contributed to the reported issue.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 event was related to a manufacturing or design issue, no corrective actions will be taken at this time.

• Brand Name: G2 COMPLEX XTRASOFT COIL 2.5X3
• Common Device Name: ORBIT GALAXY ENPOWER XTRASOFT
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel CH-24 00; SZ CH-2400
• MDR Report Key: 8708416
• Report Number: 3008114965-2019-01056
• Device Sequence Number: 1822090
• Product Code: KRD
• UDI-Device Identifier: 10878528008917
• UDI-Public: 10878528008917
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• PMA/510(K) Number: K120686
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/26/2019

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: 641CX2535
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2019
• Initial Date Received by Manufacturer: 05/26/2019
• Supplement Date Received by Manufacturer: 07/30/2019; 10/29/2019
• Initial Report FDA Received Date: 06/18/2019
• Supplement Report FDA Received Date: 08/19/2019; 11/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MICROCATHETER
• Patient Age: 68 YR