MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL MICRUSPHERE 10 - PLATINUM MICROCOIL; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	SPH10040020
Medical Device Problem Code	Stretched (1601)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/14/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).It was reported that the device would be returned for analysis; however, the device has not yet been returned.Additional information will be submitted within 30 days of receipt.
Event or Problem Description
As reported by a healthcare professional, during the aneurysm embolization procedure, the microsphere coil (sph10040020/p10951) stretched.They used another one to complete the procedure.There was no report of patient injury.It was reported that the device would be returned for analysis.
Additional Manufacturer Narrative
It was reported that the device would be returned for analysis; however, the device was not returned.As reported by a healthcare professional, during the aneurysm embolization procedure, the micrusphere coil (b)(4) stretched.They used another one to complete the procedure.There was no report of patient injury.It was reported that the device would be returned for analysis.It was reported that the device would be returned for analysis; however, the device was not returned and no additional information could be obtained.The micrusphere product was not returned for investigation.A review of manufacturing documentation associated with this lot presented no issues during the manufacturing or inspection processes related to the reported complaint.The micrusphere coil stretch could not be confirmed without product return for analysis.The root cause of the event could not be determined; however, procedure/handling factors may have contributed to the event.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 issue, no corrective actions will be taken at this time.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).[conclusion]: the healthcare professional reported that during the coil embolization procedure of an aneurysm, the micrusphere 10 platinum coil 4mm x 7.5cm (sph10040020 / p10951) became stretched.Another coil was used to complete the procedure.There was no report of patient injury.Investigation summary: the device was returned coiled inside its inner pouch.Labeling on the inner pouch matches the product documented in the complaint.Picture of the device as received.Approximately 0.5 cm of embolic coil is advanced out of the distal end of the green introducer.The device is fully unsheathed.There are no apparent kinks or bends in the device positioning unit (dpu) core wire.The ball tip is intact.The embolic coil is stretched at the distal end, just proximal to the ball tip.The articulating joint is intact.The condition of the resistance heating (rh) coil is obscured by the green introducer.There is a small amount of plastic remodeling damage to the v-notch of the resheathing tool.A review of manufacturing documentation associated with this lot (p10951) 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.Investigation conclusion: the complaint that the embolic coil stretched is confirmed.There is a slight amount of stretching visible at the distal end of the embolic coil, near the ball tip.While the circumstances surrounding the reported event are unknown, stretching generally occurs when excessive retraction force is applied to a device when resistance is present.No cause for resistance can be identified from the condition of the returned device.However, the event description documents that the damage to the embolic coil occurred during the procedure.In addition, 100% of devices are inspected for damage to the embolic coil during final assembly per mps-prp0246 rev.9.Thus, it is very unlikely that the device left the manufacturing facility with the observed damage.Device history lot: a review of manufacturing documentation associated with this lot (p10951) 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.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.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: MICRUSPHERE 10 - PLATINUM MICROCOIL
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel ; SZ
• MDR Report Key: 6885963
• Report Number: 2954740-2017-00273
• Device Sequence Number: 801255
• Product Code: HCG
• UDI-Device Identifier: 00878528003540
• UDI-Public: (01)00878528003540(17)201031(10)P10951
• 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: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/30/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2020
• Device Catalogue Number: SPH10040020
• Device Lot Number: P10951
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2018
• Initial Date Received by Manufacturer: 08/30/2017
• Supplement Date Received by Manufacturer: 11/08/2017; 06/28/2018
• Initial Report FDA Received Date: 09/22/2017
• Supplement Report FDA Received Date: 11/08/2017; 07/18/2018
• Patient Sequence Number: 1