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

Catalog Number	CFS10020830
Medical Device Problem Codes	Stretched (1601); 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) mfg name - codman & shurtleff, inc.Dba depuy synthes products, inc.This complaint met mdr reporting criterial on (b)(4) 2017 when during product analysis, the coil was found to be bent.Patient age, gender, weight and medical history were unknown.Conclusion: lot s11705 was returned with its inner pouch.Labeling on the inner pouch matches the product documented in the complaint.The device does not have its introducer.The embolic coil is tangled around the device positioning unit (dpu).There are kinks in the dpu core wire approximately 116 cm and 127 cm from the proximal end.The dpu core wire has a series of bends in the range of approximately 19 cm to 40 cm from the proximal end.The ball tip is intact.The embolic coil is stretched.The articulating joint and resistance heating (rh) coil are damaged.Advancement cannot be tested because the device does not have its 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 cannot be confirmed because the device was returned without its introducer.The kinks and bends in the dpu core wire, stretched embolic coil, and damaged articulating joint and rh coil are all indicative that excessive force was applied to the device.Without the device¿s introducer, no further conclusions can be drawn regarding the cause of the reported resistance.There is no current safety signals identified related to the reported events based on review of complaint histories 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)and (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: 7062315
• Report Number: 3013875781-2017-00037
• Device Sequence Number: 13792486
• Product Code: HCG
• UDI-Device Identifier: 00878528000150
• UDI-Public: (01)00878528000150(17)210831(10)S11705
• 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: 08/31/2021
• Device Catalogue Number: CFS10020830
• Device Lot Number: S11705
• 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