MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL G2 COMPLEX XTRASOFT COIL 2.5X2; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	641CX2525
Medical Device Problem Codes	Difficult to Remove (1528); Unraveled Material (1664); Physical Resistance (2578)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/08/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Protocode: krd/hcg.Physical manufacturer: (b)(4).Information regarding patient age, gender, weight, race, ethnicity, and medical history were not provided.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
As reported by an affiliate, during a coil embolization to an aneurysm of the anterior communicating artery (acom), there was so much of resistance while pushing the g2 complex xtrasoft coil (641cx2525, p10067) into the echelon10 microcatheter (mc).There were difficulties removing the coil from the patient, the coil became stretched.Therefore, both the coil with the microcatheter were removed and there was loss of cerebral target position.The mc was placed again at the target site.There was a clinically significant delay in the procedure of around 8-10 minutes.There was no patient injury reported.The device will be returned for analysis.There was no excessive force used at any time during the procedure.Prior to this coil, 4 other coils were deployed using the same mc without resistance.There were no kinks in the mc that may have contributed to the event.Adequate continuous flush was maintained through the catheter.
Additional Manufacturer Narrative
Updated fields: section d10, g4, g7 and h2.Additional information will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
Product complaint # (b)(4).Complaint conclusion: as reported by an affiliate, during a coil embolization to an aneurysm of the anterior communicating artery (acom), there was so much of resistance while pushing the g2 complex xtrasoft coil (641cx2525, p10067) into the echelon10 microcatheter (mc).There was difficulties removing the coil from the patient, the coil became stretched.Therefore, both the coil with the microcatheter were removed and there was loss of cerebral target position.The mc was placed again at the target site.There was a clinically significant delay in the procedure of around 8-10 minutes.There was no patient injury reported.There was no excessive force used at any time during the procedure.Prior to this coil, 4 other coils were deployed using the same mc without resistance.There were no kinks in the mc that may have contributed to the event.Adequate continuous flush was maintained through the catheter.The device was returned with its inner pouch.Labeling on the inner pouch matches the product documented in the complaint.The embolic coil is partially extended out of the green introducer, stretched, and tangled around the device positioning unit (dpu).The device was gently untangled.The device is mostly sheathed.There is a kink in the dpu core wire approximately 180 cm from the proximal end, in the sheathed section.The ball tip is intact.The embolic coil is severely stretched.The articulating joint is intact.The condition of the resistance heating (rh) coil is obscured by the green introducer.There is a small amount of plastic remodeling damage to the v-notch of the resheathing tool.Advancement and retraction cannot be tested because the embolic coil is severely stretched.A review of manufacturing documentation associated with this lot presented no issues during the manufacturing or inspection processes related to the reported complaint.The complaint that the embolic coil is unraveled or stretched is confirmed.The coil is severely stretched.The complaint that there is resistance or friction between the embolic coil and the microcatheter cannot be directly confirmed because the coil is severely stretched.However, the kink in the dpu core wire is evidence that excessive force was applied to the device, possibly in an attempt to overcome the reported resistance.The complaint that there was withdrawal difficulty into the microcatheter cannot be directly confirmed because the coil is severely stretched.However, the evidence that the embolic coil is stretched suggests that there may have been difficulty retracting the embolic coil.Stretching occurs when excessive retraction force is applied to the device while the embolic coil is prevented from retracting.The microcatheter in use during the procedure was not returned.Without return of this device, the cause of the stretching cannot be identified.Based on the device history record review, there is no indication that the event is related to the device manufacturing process.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.

• Brand Name: G2 COMPLEX XTRASOFT COIL 2.5X2
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel CH-24 00; SZ CH-2400
• MDR Report Key: 7317296
• Report Number: 3008114965-2018-00557
• Device Sequence Number: 13480180
• Product Code: KRD
• UDI-Device Identifier: 10878528008900
• UDI-Public: 10878528008900
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K120686
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/08/2018

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: Health Professional
• Device Expiration Date: 02/28/2020
• Device Catalogue Number: 641CX2525
• Device Lot Number: P10067
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2018
• Initial Date Received by Manufacturer: 02/08/2018
• Supplement Date Received by Manufacturer: 03/19/2018; 05/01/2018
• Initial Report FDA Received Date: 03/06/2018
• Supplement Report FDA Received Date: 04/16/2018; 05/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1