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

Catalog Number	FSR10020820
Medical Device Problem Codes	Stretched (1601); Physical Resistance (2578)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/19/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Mfg name - codman & shurtleff, inc.Dba depuy synthes products, inc.Conclusion: the device was returned in its inner pouch.The labeling on the pouch matches the product documented in the complaint.The device is fully unsheathed.There appears to be blood on the embolic coil, which is tightly wrapped around the dpu core wire.The re-sheathing tool has been advanced all the way to the green introducer.The embolic coil was gently disentangled from the dpu core wire.There are bends in the dpu core wire at approximately 45 cm, 51 cm, and 80 cm.The proximal end of the embolic coil is stretched.There was blood on the distal end of the embolic coil.The ball tip was intact.The articulating joint had been damaged.There is no indication of blood in the green introducer or the translucent introducer sheath.The v-notch was undamaged.An attempt was made to re-sheath the embolic coil to attempt advancing it through a microcatheter.When the re-sheathing tool passed over the first bend in the dpu core wire the core wire could not re-sheath and protruded from the translucent introducer sheath.Advancement through a microcatheter could not be attempted.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 was impeded in the microcatheter could not be confirmed.Advancement could not be attempted because the coil could not be re-sheathed.While the exact circumstances are unknown, the evidence of the stretched coil and the bends in the dpu core wire indicate that excessive force was applied, possibly in an attempt to overcome resistance.In addition, the presence of blood at the distal end of the microcatheter suggests that an 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.This is an initial/final mdr.
Event or Problem Description
As reported by a healthcare professional, during coil embolization at an unknown location, an ultipaq coil (fsr10020820/ s10351) could not be placed into the entrance of an unspecified catheter and during product analysis, it was determined that the coil was stretched.The same type coil advanced through the same catheter afterward.There was no potential adverse event to the patient and the procedure was delay 5 minutes.

• Brand Name: ULTIPAQ - PLATINUM MICROCOIL
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; rue girardet 29; le locle jura ; SZ
• MDR Report Key: 6947548
• Report Number: 1226348-2017-00173
• Device Sequence Number: 10985821
• Product Code: HCG
• UDI-Device Identifier: 00878528001553
• UDI-Public: (01)00878528001553(17)210331(10)S10351
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 07/24/2017

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: 03/31/2021
• Device Catalogue Number: FSR10020820
• Device Lot Number: S10351
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/12/2017
• Initial Report FDA Received Date: 10/13/2017
• Patient Sequence Number: 1