MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL MICRUSFRAME COIL; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	MFR100517
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/08/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Procode: krd/hcg.Concomitant medical products: a guiding catheter (7f roadmaster, goodman), a micro catheter (sl-10 90°stryker),a balloon catheter (transform 4*10) were also used for this procedure.(b)(6).Additional information will be submitted within 30 days of receipt.
Event or Problem Description
As reported by a healthcare professional, during coil embolization of an internal carotid artery aneurysm (c2) a micrusframe 10 coil (mfr100517/ s12171) protruded into the parent vessel and the coil could not be re-sheathed due to sheath damage, and another micrusframe 10 coil (mfr100517/ s12171) could not be inserted through the microcatheter hub.The microcatheter was approached to the lesion and the micursframe10 (complaint product) was stuck in the sl 10 microcatheter hub and could not be advanced.The coil was used for framing, but the coil come out to the parent vessel, so a transform balloon was inflated.At the time, the balloon slipped, and come out with the microcatheter.The physician tried to re-sheath the coil, but the sheath introducer became damaged and the device could not be used at all.The microcatheter was changed to the another one (90°shape) and it was reinserted into the lesion.The coil was replaced with another micrusframe 10 (second complaint product) and they attempted to insert it into the microcatheter, but it got stuck at the hub and could not be advance.It was flushed in the y connector and they attempted to reinsert, but the coil could not be inserted.The coil was replaced with competitive one.The procedure was successfully completed without further issues or delay.There was also no patient injury / complication reported.The complaint product was new and stored per labeling instructions.The procedure was conducted in accordance with the ifu and the constant flush had been maintained at all time.No visible defect/damage was noted on the products prior to the event.No unintended detachment was observed in the vessel or in the microcatheter.The products are not available for investigation.No further information is available.
Additional Manufacturer Narrative
Additional information will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
Conclusion: the micrusframe product (lot s12171) was not returned for investigation.A review of manufacturing documentation associated with this lot presented no issues during the manufacturing or inspection processes related to the reported complaint.The coil protrusion and resheathing issue could not be confirmed without product return for analysis.The root cause of the events could not be determined; however, procedural/handling factors may have contributed to the events.There is no current safety signal identified related to the reported events based on reviews of complaint histories for the device.Since there was no evidence to suggest the events was related to a manufacturing issues, no corrective actions will be taken at this time.

• Brand Name: MICRUSFRAME COIL
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel ; SZ
• MDR Report Key: 6838243
• Report Number: 2954740-2017-00247
• Device Sequence Number: 11143504
• Product Code: HCG
• UDI-Device Identifier: 10886704077831
• UDI-Public: (01)10886704077831(17)190930(10)S12171
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K150319
• 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,Followup,Followup
• Report Date (Section B): 08/09/2017

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: 09/30/2019
• Device Catalogue Number: MFR100517
• Device Lot Number: S12171
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/09/2017
• Supplement Date Received by Manufacturer: 08/09/2017; 10/23/2017
• Initial Report FDA Received Date: 09/01/2017
• Supplement Report FDA Received Date: 09/01/2017; 10/25/2017
• Patient Sequence Number: 1