MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL PRESIDIO 18 CERE 12MMX40CM; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	PC418124030
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/14/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, age, gender, weight, race, ethnicity, and medical history were not provided.Initial reporter phone: (b)(6); initial reporter email was not reported.Physical manufacturer name: codman and shurtleff inc., dba depuy synthes products, inc.((b)(4)).The device is available to be returned for evaluation and testing.However, it has not been received to date as indicated as ¿other¿ in this section as the reason for non-evaluation.If the device returns, a device investigation will be performed.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.
Event or Problem Description
The healthcare professional reported that during the coil embolization procedure to treat an intracranial aneurysm, the 12mm x 40cm presidio 18 cerecyte coil ((b)(4)/ l14086) could not be detached using the enpower control cable and the enpower detachment control box (dcb).A pre-deployment check was performed, and the low battery and fault lights were not observed.It was reported that upon pressing the power button, all the lights illuminated on the enpower dcb, but the green system ready light did not illuminate.The coil was successfully removed and replaced; the coil was still attached to the delivery system and not stretched when it was removed.The procedure was completed using the same enpower dcb and enpower control cable; there was no report of any patient adverse event or complication; no procedural delay.It was reported that the product is available to be returned for evaluation.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to document the result of the analysis of the production records for lot l14086.A review of manufacturing documentation associated with this lot (l14086) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no non-conformances related to device manufacture or inspection.All product rejected during manufacturing was identified as scrap and properly accounted for.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to report that the product was received by the product analysis lab on 6/27/2019.The return product is pending evaluation.A supplemental 3500a report will be submitted once the product investigation has been completed.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to report the investigational finding of the returned device.[conclusion]: the healthcare professional reported that during the coil embolization procedure to treat an intracranial aneurysm, the 12mm x 40cm presidio 18 cerecyte coil (pc418124030 / l14086) could not be detached using the enpower control cable and the enpower detachment control box (dcb).A pre-deployment check was performed, and the low battery and fault lights were not observed.It was reported that upon pressing the power button, all the lights illuminated on the enpower dcb, but the green system ready light did not illuminate.The coil was successfully removed and replaced; the coil was still attached to the delivery system and not stretched when it was removed.The procedure was completed using the same enpower dcb and enpower control cable; there was no report of any patient adverse event or complication; no procedural delay.The product was returned for evaluation and analysis.The investigational finding is documented below.Investigation summary: the non-sterile 12mm x 40cm presidio 18 cerecyte coil was received contained in a pouch.The device underwent visual inspection.The hub, resheathing tool, v-notch, rh (resistance heating), coil introducer, device positioning unit (dpu) and the embolic coil appeared in normal condition.The rh did not show evidence of being heated.Functional test was performed.The device resistance was measured with a multimeter and the enpower control cable to be 54.6 ohms (specification = 48.5 ohms to 56.0 ohms).The resistance was within specification.The device was connected to a detachment control box ((b)(6)) and the power was turned on.The green system ready light illuminated.The detachment cycle was initiated when the detach button was pressed.The coil detached without any issues.A review of manufacturing documentation associated with this lot (l14086) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no non-conformances related to device manufacture or inspection.All product rejected during manufacturing was identified as scrap and properly accounted for.The reported issue that the 12mm x 40cm presidio 18 cerecyte coil could not be detached using the enpower control cable and the enpower dcb was not confirmed through functional test.The coil was detached without any issue.As part of the post market surveillance program, information from this complaint is trended for statistical signals and corrective/preventive action may be triggered at a later time.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.Updated sections: g.4, g.7, h.2, h.3, h.6, and h.10.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.

• Brand Name: PRESIDIO 18 CERE 12MMX40CM
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel CH-24 00; SZ CH-2400
• MDR Report Key: 8689512
• Report Number: 3008114965-2019-01032
• Device Sequence Number: 19426288
• Product Code: HCG
• UDI-Device Identifier: 00878528003243
• UDI-Public: 00878528003243
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/22/2019

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: 09/30/2023
• Device Catalogue Number: PC418124030
• Device Lot Number: L14086
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2019
• Initial Date Received by Manufacturer: 05/22/2019
• Supplement Date Received by Manufacturer: 06/20/2019; 06/27/2019; 07/15/2019
• Initial Report FDA Received Date: 06/11/2019
• Supplement Report FDA Received Date: 06/20/2019; 06/27/2019; 07/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1