MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL DELTAPAQ CERE 2MMX4CM; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number CDF100204-30

Device Problem Stretched (1601)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/29/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).This initial mdr will be the only report submitted for mfr report #3008114965-2017-00518.Additional patient and initial reporter information, but not yet received.(b)(4).The product has been forwarded to codman for evaluation and testing, however the analysis has not been completed.Additional information will be submitted within 30 days of receipt.

Event Description

It was reported by a healthcare professional that a deltapaq coil (b)(4) was used during a procedure and the coil stretched.Another coil was used to complete the procedure and there was no report of patient injury.

Manufacturer Narrative

Product complaint #
=
> (b)(4).This final mdr will be the only report submitted for mfr report #3008114965-2017-00518.Conclusion: the device was returned with its inner pouch.Labeling on the inner pouch matches the product documented in the complaint.The embolic coil is detached from the device positioning unit (dpu) and was not returned.The resheathing tool is broken.The distal end of the resheathing tool has been advanced nearly to the distal end of the green introducer.The dpu core wire is kinked at the strain relief and at the broken end of the proximal portion of the resheathing tool.The dpu core wire is severely bent in the vicinity of the green introducer, between approximately 13 and 25 cm from the proximal end of the device.The pet outer sheath is partially stripped from the dpu core wire between approximately 59 and 63 cm from the proximal end of the device.The dpu core wire is severely bent approximately 66 cm, 69 cm, between approximately 110 and 112 cm, and approximately 150 cm from the proximal end.The resistance heating (rh) coil has heated, melting its pet sheath.The dpu core wire is damaged at several locations.The distal end of the green introducer is damaged.While the resheathing tool is broken, its v-notch is undamaged.A review of manufacturing documentation associated with this lot 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 complaint that the embolic coil stretched cannot be confirmed.The embolic coil is detached from the dpu and was not returned.While the exact sequence of events is unknown, the evidence of the heated rh coil suggests that the embolic coil was placed and detached.There is significant damage to the dpu, including damage to the pet outer sheath in several locations.The broken resheathing tool, kinks and bends in the dpu core wire, damage to the green introducer, and damage to the dpu¿s pet outer sheath are all indicative of the application of excessive force.The reason for the application of force is not apparent from the event description or from examination of the returned device.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.

Manufacturer Narrative

(b)(4).This follow-up mdr will be the only report submitted for mfr report #3008114965-2017-00518.Additional information received on january 02, 2018.The name of the facility is affiliated hospital of (b)(6), located at (b)(6).The intended procedure was embolization of an intracranial aneurysm.There was no damage noted to the device prior to the procedure.No kinks or bends were noted to the microcatheter that may have contributed to the reported event.An adequate continuous flush was maintained through the catheter at all times.The entire coil was removed from the patient still attached to the delivery system, while the microcatheter remained in place at the target site.There were no adverse events to the patient.There was no procedural delay as a result of the event and neither the complaint device, nor the concomitant devices, are available for evaluation.Additional information will be reported within 30 days of receipt.

• Brand Name: DELTAPAQ CERE 2MMX4CM
• Type of Device: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel CH-24 00; SZ CH-2400
• Manufacturer (Section G): CODMAN AND SHURTLEFF INC.; 47709 fremont blvd; fremont CA 94538
• Manufacturer Contact: gabriel alfageme ; chemin-blanc 38; le locle neuchatel CH-24-00 ; SZ CH-2400 ; 6506874920
• MDR Report Key: 7153560
• MDR Text Key: 96118071
• Report Number: 3008114965-2017-00518
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00878528007081
• UDI-Public: (01)00878528007081(17)200531(10)C36101
• Combination Product (y/n): N
• PMA/PMN Number: K080437
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 11/30/2017

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
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2020
• Device Model Number: CDF100204-30
• Device Catalogue Number: CDF10020430
• Device Lot Number: C36101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/29/2017
• Initial Date Manufacturer Received: 11/30/2017
• Initial Date FDA Received: 12/28/2017
• Supplement Dates Manufacturer Received: 11/30/2017; 03/12/2018
• Supplement Dates FDA Received: 01/31/2018; 04/11/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1