MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL DELTAXSFT10 3MM X 6CM; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	DLX100306
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	Rupture (2208)
Date of Event	06/17/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Procode: krd/hcg.Initial reporter: the customer contact information, including name, occupation, phone, fax, and e-mail address, was not reported.The device is available to be returned for evaluation and testing.However, it has not been received to date.If the device returns, a device investigation will be performed.The company is seeking this information through the event investigation.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.
Event or Problem Description
A report from the field indicated that after detaching the 3mm x 6cm deltaxsft10 (dlx100306/l16594) coil and retracting the delivery wire, the physician noticed that the proximal segment of the microcoil was still inside the sl-10 (stryker) microcatheter.The physician tried to push the coil out of the distal end of the microcatheter using a microwire, but it seemed to be stuck in the microcatheter.The microwire was changed and the physician pushed hard since smaller force did not make the coil move.Finally, the physician released the coil from the microcatheter, but in doing so, the lateral wall of the aneurysm ruptured.The procedure was completed with competitor coils and the same microcatheter.Per the treating physician, the patient was stable following the procedure.No further information was provided at the time of complaint initiation.
Additional Manufacturer Narrative
Product complaint # (b)(4).Updated sections on this report: d10, g4, g7, h2, h3, h6 and h10.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.Complaint conclusion: a report from the field indicated that after detaching the 3mm x 6cm deltaxsft10 (dlx100306/l16594) coil and retracting the delivery wire, the physician noticed that the proximal segment of the microcoil was still inside the sl-10 (stryker) microcatheter.The physician tried to push the coil out of the distal end of the microcatheter using a microwire, but it seemed to be stuck in the microcatheter.The microwire was changed and the physician pushed hard since smaller force did not make the coil move.Finally, the physician released the coil from the microcatheter, but in doing so, the lateral wall of the aneurysm ruptured.The procedure was completed with competitor coils and the same microcatheter.Per the treating physician, the patient was stable following the procedure.One non-sterile deltaxsft10 3mm x 6cm was received inside of a pouch.The device was visually inspected, and no damages were noted on it.Then a microscopic inspection was performed, the distal outer sheath had been softened indicating that the resistance heating coil had been heated and the detachment process was initiated, the embolic coil was not returned for evaluation, no other damages could be observed on the device.The marker band was found at 41cm from distal end and it was found within specification.A manufacturing record evaluation was performed for the finished device l16594 number, and no non-conformances related to the reported complaint condition were identified.Coil impeded in microcatheter and aneurysm rupture are known potential complications associated with coil embolization procedures.Manipulation of devices in or near the intracranial aneurysm increases the risk of rupturing the fragile aneurysm wall.With the information provided, it is not possible to determine the root cause of the event; however, clinical and procedural factors, including aneurysm/vessel characteristics, device selection, device interaction, and operator technique, may have contributed.Due to covid19 and quarantine restrictions, no additional information has been able to be obtained from the reporter.The file will be re-reviewed if additional information is received at a later date.As part of the post market surveillance program, information from this complaint is trended to identify statistical signals for consideration of further correction action.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.

• Brand Name: DELTAXSFT10 3MM X 6CM
• 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: 10270364
• Report Number: 3008114965-2020-00280
• Device Sequence Number: 13667998
• Product Code: KRD
• UDI-Device Identifier: 10886704077350
• UDI-Public: 10886704077350
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K150319
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2022
• Device Model Number: DLX100306
• Device Catalogue Number: DLX100306
• Device Lot Number: L16594
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2020
• Initial Date Received by Manufacturer: 06/22/2020
• Supplement Date Received by Manufacturer: 07/20/2020
• Initial Report FDA Received Date: 07/14/2020
• Supplement Report FDA Received Date: 08/12/2020
• 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: SL-10 (STRYKER) MICROCATHETER; UNSPECIFIED MICROWIRE
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention