MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL DELTAXTRASOFT COIL; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	DLX100306
Medical Device Problem Code	Difficult To Position (1467)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	06/13/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This initial mdr is the only report being submitted.Procode: krd/hcg.(b)(4).The product will not be returned for analysis however a device history record review is currently being conducted and the results are not yet available.Additional information will be submitted within 30 days of receipt.
Event or Problem Description
It was reported by a healthcare professional that, during a distal anterior cerebral artery coiling procedure, a micrus frame s 5x10 coil (mfr100509/s11178) kicked up a number of times and the prowler 14 microcatheter (unknown product code/lot) jumped out of the aneurysm 6 to 7 times with a deltaxsft 10 coil (dlx100306/s11751); therefore, the physician decided to remove this coil from the system.A micrus frame s 5 x 10 coil was used with the same microcatheter prior to the deltaxsft 10 coil (complaint product 1) and the prowler 14 microcatheter (complaint product 3) kicked up a number of times.However, the physician was able to deploy the micrus frame s 5 x 10 coil (complaint product 2) after 3 attempts.The prowler 14 microcatheter was not removed from the patient and the physician completed the procedure with blockade coils.The procedure was delayed 30 minutes.On (b)(6) 2017, the patient experienced a mild stroke post procedure.It is unknown how the stroke was treated.Reportedly, the patient has made a complete recovery and is being discharged to their home neuro intact.The patient's information is unknown; however, the target vessel was reported to be distal a2 with small and tortuous vessels.There were no kinks or bends noted to the prowler 14 microcatheter that may have contributed to the event.No damage was noted to the coils prior to use or upon removal of the deltaxsft 10 from the prowler 14 microcatheter.The introducer was fully seated and secured in the catheter hub during introduction of the device into the catheter.In the physician's assessment, the relationship between the codman devices and the mild stroke is unknown.
Additional Manufacturer Narrative
This final mdr will be the only report submitted for mfr report #2954740-2017-00199.Based on the information, the event could not be confirmed.The product was not returned for analysis; however 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.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.

• Brand Name: DELTAXTRASOFT COIL
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel ; SZ
• MDR Report Key: 6706392
• Report Number: 2954740-2017-00199
• Device Sequence Number: 16574909
• Product Code: KRD
• UDI-Device Identifier: 10886704077350
• UDI-Public: (01)10886704077350(17)190731(10)S11751
• Combination Product (Y/N): N
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2017

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: 07/31/2019
• Device Catalogue Number: DLX100306
• Device Lot Number: S11751
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/13/2017
• Supplement Date Received by Manufacturer: 09/14/2017
• Initial Report FDA Received Date: 07/12/2017
• Supplement Report FDA Received Date: 01/10/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention