MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL PRESIDIO 18 - CERECYTE MICROCOIL; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	PC418164730
Medical Device Problem Code	Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/07/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).Additional information will be submitted within 30 days of receipt.
Event or Problem Description
As reported by a healthcare professional, a presidio 18 coil ((b)(4), c29738) was difficult to position in the splenic artery aneurysm and the sheath introducer was damaged during attempt to re-sheath, and a presidio 18 ((b)(4)/ c15917) loop protruded into the parent vessel and could not be re-sheathed.Lot c29738 was attempted to be place in the aneurysm, but it kicked back strongly.Therefore, the physician tried to re-sheath the coil, but the sheath introducer became damaged and could not re-sheath the coil.The coil was replaced with another one.Lot c15917 was used for the 3rd coil, but the loop was out of the mother vessel from the neck and the coil could not be placed.Therefore, the physician tried to re-sheath, the coil, but the coil was could not be re-sheathed.It was replaced with another 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.It was reported that only lot c29738 was available for investigation.No further information was available.
Additional Manufacturer Narrative
Conclusion: the presidio product 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 from the aneurysm and the re-sheathing issue could not be confirmed without product return for analysis.The root cause of the events could not be confirmed; however, procedural/handling factors may have contributed to the events.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 events was related to a manufacturing issues, no corrective actions will be taken at this time.

• Brand Name: PRESIDIO 18 - CERECYTE MICROCOIL
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel ; SZ
• MDR Report Key: 6828719
• Report Number: 2954740-2017-00245
• Device Sequence Number: 13624314
• Product Code: HCG
• UDI-Device Identifier: 00878528003281
• UDI-Public: (01)00878528003281(17)180220(10)C15917
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K002056
• 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
• Report Date (Section B): 08/07/2017

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: 02/20/2018
• Device Catalogue Number: PC418164730
• Device Lot Number: C15917
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/07/2017
• Supplement Date Received by Manufacturer: 10/19/2017
• Initial Report FDA Received Date: 08/29/2017
• Supplement Report FDA Received Date: 10/25/2017
• Patient Sequence Number: 1