MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL MICRUSPHERE XL PLATINUM MICROCOIL; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	SSR10072020
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/16/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product code: krd/hcg.Udi: lot number unknown; (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.No conclusions are made at this time.
Event or Problem Description
It was reported by a healthcare professional that a micrusphere xl 7mmx20cm (ssr10072020/lot unk) failed to detach during an aneurysm coiling procedure.The doctor tried to deploy the micrusphere xl 7mmx20cm (complaint product) through the microcatheter and after deploying the coil, attached the connecting cable and pressed the detachment button; however, the coil did not detach after 5 attempts.The coil was still attached from the delivery system when it was removed from the patient.There was no change to the patient's blood flow and no change in the patient's condition.Reportedly, there were no patient complications as a result of this event.Previously, during the same case, the doctor deployed a micrusphere 15 mmx40 cm and it detached perfectly with the same cable and detachment box.The procedure was successfully completed by deploying two more medtronic axiom coils.The device is being returned for evaluation.
Additional Manufacturer Narrative
Lot information was discovered via preliminary product analysis.On (b)(6) 2017.(b)(4).Conclusion: it was reported by a healthcare professional that a microsphere xl 7mmx20cm (b)(4) failed to detach during an aneurysm coiling procedure.The doctor attempted to deploy the coil through the microcatheter, and after deploying the coil, attached the connecting cable and pressed the detachment button; however, the coil did not detach after 5 attempts.The coil was still attached from the delivery system when it was removed from the patient.There was no change to the patient's blood flow and no change in the patient's condition.Reportedly, there were no patient complications as a result of this event.Previously, during the same case, the doctor deployed a micrusphere 15 mmx40 cm and it detached perfectly with the same cable and detachment box.The device was returned for analysis.The unidentified empower detachment control band box (dcb) and the connecting cable were not returned.The unidentified microcatheter was not returned.The coil was returned undamaged.The detachment fiber did not receive heat and melt.The detachment fiber did not receive heat and melt.The device positioning unit (dpu) failed electrical testing with resistance at 0.0 ohms (range 48.5/56.0), and the lab sample enpower and cable systems ready green light also failed to illuminate.No manufacturing defects were found.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.The complaint of the coil¿s non-detachment was confirmed.The dpu failed electrical testing.While the exact root cause cannot be determined, the evidence as received highly suggests that damage to the electrical wiring with the possibility of it occurring at the solder joint connection inside the resistive heating coil section.The circumstances of how and when this damage occurred cannot be determined as all microcoil systems are electrically tested prior to final packaging.In addition, without the return of the complaint detachment system used in the procedure, it cannot be determined if these components had any additional contributions to the complaint event.

• Brand Name: MICRUSPHERE XL PLATINUM MICROCOIL
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel ; SZ
• MDR Report Key: 6253584
• Report Number: 2954740-2017-00009
• Device Sequence Number: 18854420
• Product Code: KRD
• UDI-Device Identifier: 00878528009924
• UDI-Public: (01)00878528009924
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K142429
• 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): 12/17/2016

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: 07/31/2019
• Device Catalogue Number: SSR10072020
• Device Lot Number: C28662
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/19/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/16/2017
• Supplement Report FDA Received Date: 02/24/2017
• Patient Sequence Number: 1