MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL ULTIPAQ - CERECYTE MICROCOIL; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	CFS10020830
Medical Device Problem Codes	Kinked (1339); Physical Resistance (2578)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/05/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).(b)(4).This complaint met mdr reporting criteria on 11/27/2017 when product analysis found that the coil was kinked.Patient age, gender, weight and medical history are unknown.Conclusion: product file (b)(4): lot s11458 was returned with its inner pouch.Labeling on the inner pouch matches the product documented in the complaint.The embolic coil is located in the green introducer.There is blood in the translucent introducer sheath.There is a slight bend in the device positioning unit (dpu) core wire approximately 77 cm from the proximal end.The ball tip is intact.There is blood on the embolic coil.The embolic coil is kinked.The articulating joint is damaged.There is blood throughout the translucent introducer sheath proximal to the embolic coil.The v-notch of the resheathing tool is undamaged.Damage to the articulating joint and embolic coil prevents advancement of the embolic coil out of the introducer.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 there was resistance or friction during advancement into the microcatheter cannot be confirmed.Damage to the embolic coil and articulating joint prevents advancement of the embolic coil out of the introducer and into a microcatheter.This damage, as well as the bend in the dpu core wire are evidence that excessive force was applied to the device, possibly in an attempt to overcome the reported resistance.While the exact circumstances are unknown, blood on the embolic coil and in the translucent introducer sheath proximal to the embolic coil suggest that insufficient flush was maintained.The 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.There is no current safety signal identified related to the reported event based on review of complaint history for the device.Since there was no evidence to suggest the event was related to a manufacturing issue, no corrective actions will be taken at this time.This is an initial/final mdr report.
Event or Problem Description
As reported by a healthcare professional, two ultipaq coils ((b)(4)) could not be introduced into the excelsior sl-10 microcatheter.During analysis, lot s11458 was found to be kinked and lot s11705 was stretched.There was a "bouncy resistance".Other coils and the microwire went through the microcatheter without any problems.The procedure was completed with a same/like product using the same microcatheter.A continuous flush had been maintained through the microcatheter and neither the microcatheter no the ultipaq coils appeared damaged.The coils were still attached to the dpu when removed from the patient.There was no patient injury; however, there was a 10 minute delay due to the event.

• Brand Name: ULTIPAQ - CERECYTE MICROCOIL
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; rue girardet 29; le locle jura ; SZ
• MDR Report Key: 7062302
• Report Number: 3013875781-2017-00036
• Device Sequence Number: 19311816
• Product Code: HCG
• UDI-Device Identifier: 00878528000150
• UDI-Public: (01)00878528000150(17)210721(10)S11458
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K022420
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 09/08/2017

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: 07/21/2021
• Device Catalogue Number: CFS10020830
• Device Lot Number: S11458
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/27/2017
• Initial Report FDA Received Date: 11/27/2017
• Patient Sequence Number: 1