MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL PRESIDIO 18 - CERECYTE MICROCOIL; CNV DCS COILS

Catalog Number PC418184630

Device Problems Difficult to Fold, Unfold or Collapse (1254); Difficult To Position (1467)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/18/2015

Event Type  malfunction  

Manufacturer Narrative

The presidio will not be returned, therefore the root cause of the positioning difficulty and the inability to re-sheath the coil cannot be determined.Dhr: a review of the manufacturing documentation associated with this lot presented no issues during the manufacturing or inspection process that can be related to the reported complaint.Based on the information, the event could not be confirmed.The product was not returned for analysis; however a review of the manufacturing documentation associated with this lot presented no issues during the manufacturing or inspection process that can be related to the reported complaint.Therefore, no corrective actions will be taken at this time.(b)(4).

Event Description

The contact from the facility reported that during embolization of an 18mm aneurysm at the sphenopalatine artery a presidio coil ((b)(4)) did not fill the aneurysm as expected and the coil could not be resheathed.The patient's vessels were heavily torturous and mildly calcified.A sheath introducer by terumo (type unknown), an aqua v3 (cordis), a 4fr angiographic guiding catheter by unknown manufacturer, an excelsior 1018 (stryker), and enpower dcb /cable (lots unknown) were used for this procedure.After two presidio coils (both are (b)(4) / lots unknown) were successfully implanted into the aneurysm, the complaint presidio was chosen next.Although it was delivered to the aneurysm, because the microcoil did not loop as the physician wished, it was decided to recover the coil once.However, it was discovered that the distal end of the introducer sheath was split open, and thus the microcoil could not be re-sheathed.The procedure was successfully completed after implanting several more coils (cashmere and deltamaxx).There were no further issues or delay, and no patient injury / complications.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 times.No visible damage was noted on the product prior to the event.The complaint device is not available for analysis.No further information is available.

• Brand Name: PRESIDIO 18 - CERECYTE MICROCOIL
• Type of Device: CNV DCS COILS
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel ; SZ
• Manufacturer Contact: kimberly soter ; 821 fox lane; san jose, CA 95131 ; 5089777396
• MDR Report Key: 5352334
• MDR Text Key: 35314081
• Report Number: 2954740-2016-00007
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• PMA/PMN Number: K002056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2015
• Device Catalogue Number: PC418184630
• Device Lot Number: C34513
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/21/2015
• Date Device Manufactured: 04/15/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 46 YR