MAUDE Adverse Event Report: PRESIDIO 10 CERE 6MMX26CM; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	PC4100626-30
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/05/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).This initial mdr will be the only report submitted for this.Several attempts were made to obtain additional information; however, a response was not received.Therefore, further patient and procedural information is unavailable.(b)(4).The product is expected to be returned for analysis, however it has not been received.Additional information will be submitted within 30 days of receipt.
Event or Problem Description
It was reported by a healthcare professional that a presidio 10 coil (pc410062630/s10208) was used during a procedure when the coil could not be detached.The physician withdrew the coil and used another to complete the procedure.There was no report of patient injury.
Additional Manufacturer Narrative
(b)(4).This final mdr will be the only report submitted for mfr report #2954740-2017-00502.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.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 event was related to a manufacturing or design issue, no corrective actions will be taken at this time.
Additional Manufacturer Narrative
Product complaint # (b)(4).This follow-up mdr will be the only report submitted for mfr report #2954740-2017-00502.Additional information received on december 21, 2017.(b)(6).

• Brand Name: PRESIDIO 10 CERE 6MMX26CM
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• MDR Report Key: 7089098
• Report Number: 2954740-2017-00502
• Device Sequence Number: 11179855
• Product Code: HCG
• UDI-Device Identifier: 00878528003021
• UDI-Public: (01)00878528003021(17)210331(10)S10208
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K082739
• 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): 12/04/2017

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 Model Number: PC4100626-30
• Device Catalogue Number: PC410062630
• Device Lot Number: S10208
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 11/07/2017
• Supplement Date Received by Manufacturer: 12/21/2017; 01/22/2018
• Initial Report FDA Received Date: 12/06/2017
• Supplement Report FDA Received Date: 01/19/2018; 02/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1