MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL DELTAXSFT10 1.5MM X 3CM; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	DLX100153
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/19/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, weight, race, ethnicity, and medical history were not provided.Procode is krd/hcg.The name, phone and email address of the initial reporter are not available / reported.Conclusion: the healthcare professional reported that during the cerebral aneurysm repair procedure, it was reported that the 1.5mm x 3cm deltaxsft 10 coil (dlx100153 / l16826) would not advance out of the coil introducer into the microcatheter hub.The coil was removed and replaced with another coil.The procedure was successfully completed without any procedural delay.There was no report of any patient adverse event or complication.The complaint coil was returned for evaluation and analysis.The investigational finding is documented below.Investigation summary: the non-sterile 1.5mm x 3cm deltaxsft 10 coil was received contained in a pouch.Visual inspection was performed.The device positioning unit (dpu) was protruding from the introducer.The dpu is in good condition; the introducer is kinked.The marker band was found at 38cm from the hub.This is within specification.Microscopic inspection was performed.The embolic coil was observed protruding from the intruder and in stretched condition.Functional test was precluded due to the condition of the device.The dpu of the returned device is protruding from the introducer.The coil introducer is kinked.A review of manufacturing documentation associated with this lot (l16826) 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 reported that the 1.5mm x 3cm deltaxsft 10 coil would not advance out of the introducer into the microcatheter hub.The kinked introducer and the dpu being protruded from the introducer precluded the device from functional evaluation, however, them embolic coil was also observed kinked under microscopic magnification.While the issue could not be confirmed through functional evaluation, the appearance of the complaint device likely contributed to the issue reported in the complaint.The embolic coil may have become kinked during the attempt to advance the coil out of the introducer.Coil kinking is a known potential issue associated with the use of the device.The instruction for use (ifu) provides proper handling instructions for the device to prevent issues such as kink from occurring.The kinked condition observed on the embolic coil of the returned device was not originally reported with the complaint.The exact cause of the observed kinked condition could not be conclusively determined; however, it may have occurred when the issue was reported, that the ocil would not advance out of the introducer into the microcatheter hub.Attempt to advance the coil out of the introducer may have resulted in inadvertent forced exerted on the device resulted in the kinked embolic coil, kinked introducer, and caused the dpu to protrude from the introducer.Based on the device history record review, there is no indication that the event is related to the device manufacturing process.In addition, devices undergo 100% inspection at final assembly for the condition of the embolic coil.Thus, it is not likely that the 1.5mm x 3cm deltaxsft 10 coil 1.5mm x 3cm deltaxsft 10 coil left the manufacturing facility with the embolic coil in the observed kinked condition.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.
Event or Problem Description
The healthcare professional reported that during the cerebral aneurysm repair procedure, it was reported that the 1.5mm x 3cm deltaxsft 10 coil (dlx100153 / l16826) would not advance out of the coil introducer into the microcatheter hub.The coil was removed and replaced with another coil.The procedure was successfully completed without any procedural delay.There was no report of any patient adverse event or complication.The complaint device was returned for evaluation.During the visual / microscopic inspection of the returned device, the embolic coil was observed to be in kinked condition.Based on the product analysis 9/25/2020, this event has been deemed mdr reportable as a ¿malfunction.¿.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).The purpose of this mdr is to include the additional event information received on 9/28/2020.[additional event information]: the healthcare professional reported that during the cerebral aneurysm repair procedure targeting an unruptured aneurysm on the supraclinoid segment of the right internal carotid artery (ica), it was reported that the 1.5mm x 3cm deltaxsft 10 coil (dlx100153 / l16826) would not advance out of the coil introducer into the excelsior® sl-10® microcatheter (stryker) hub.The coil was removed and replaced with another coil.After the coil was removed, an attempt was made at the table on the sterile field to get the coil to exit the coil introducer, but it would not exit.The coil was replaced.There were no issues with the subsequent coil; a galaxy g3 mini was put through the same microcatheter as the next to las coil without any problems.It was reported that there were other coils used with the concomitant microcatheter without any issue.Continuous flush was maintained through the microcatheter.The microcatheter did not appear damage during the manipulation prior to or after the reported issue.It was also reported that the tip of the coil introducer was firmly instaled into the hub of the concomitant microcatheter and locked with the rotating hemostasis valve (rhv) during the attempt to advance the coil.Force was not applied and the reported issue di not result in the loss of the target position.The coil was replaced, and the procedure was successfully completed without any procedural delay.There was no report of any patient adverse event or complication.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: DELTAXSFT10 1.5MM X 3CM
• 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: 10596983
• Report Number: 3008114965-2020-00437
• Device Sequence Number: 372610
• Product Code: KRD
• UDI-Device Identifier: 10886704077268
• UDI-Public: 10886704077268
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K150319
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2020

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: 08/31/2022
• Device Model Number: DLX100153
• Device Catalogue Number: DLX100153
• Device Lot Number: L16826
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2020
• Initial Date Received by Manufacturer: 09/28/2020
• Supplement Date Received by Manufacturer: 09/28/2020
• Initial Report FDA Received Date: 09/28/2020
• Supplement Report FDA Received Date: 09/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DELTAXSFT10 1.5MM X 2CM.; EXCELSIOR SL-10® MICROCATHETER (STRYKER).; GALAXY G3 MINI 1.5MM X 2CM.; MICRUSFRAME14 4MM X 8CM.
• Patient Age: 51 YR