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

Catalog Number DLX100306

Device Problems Premature Activation (1484); Stretched (1601)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/02/2017

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: enterprise2 4mm x 30mm stent, sl10 coiling catheter in place micrusframe 5mm x 9.7cm microcoil, galaxy g3 4mm x 8cm coil, galaxy 4mm x 6cm coil.Mfg name: codman & shurtleff, inc.Dba depuy synthes products, inc.The device was returned for analysis; however, the analysis has not yet been completed.Additional information will be submitted within 30 days of receipt.

Event Description

As reported via a health professional, a deltaxsft (dlx100306/ s14198) prematurely detached while being positioned in the 5.5mm carotid terminus aneurysm.An enterprise2 4mm x 30mm stent have been placed successfully and the physician had jailed the sl10 coiling catheter in place.The aneurysm successfully framed with a micrusframe 5mm x 9.7cm microcoil.This was followed by a galaxy g3 4mm x 8cm coil and then an additional galaxy 4mm x 6cm coil.The deltaxsft 3mm x 6cm coil (complaint coil) was chosen for the next coil, but it unintentionally detached during placement into the aneurysm.Approximately 2/3 of the coil was placed in the aneurysm when the physician began to reposition the coil.After a small amount of movement pulling the coil out and advancing it, the physician decided he did not have control of the coil and felt it had detached.The physician confirmed he could not remove the coil.The coil detached in the microcatheter without activating the enpower cable.It appeared to detach with minimal manipulation by the physician.He then successfully pushed the remaining approx.1.5cm of coil into the aneurysm, but it was in a position that was not completely secured with the rest of the coil mass.Ultimately, he felt the coil was well protected from the parent artery by the stent, so the procedure was concluded successfully.After the case, the physician remarked that he felt some resistance when repositioning the coil, but did not feel he pulled the coil with considerable force that would detach the coil.The patient was doing well at conclusion of the procedure.It was reported that the device would be returned for analysis.

Manufacturer Narrative

As reported via a health professional, a deltaxsft (dlx100306/s14198) prematurely detached while being positioned in the 5.5mm carotid terminus aneurysm.An enterprise2 4mm x 30mm stent have been placed successfully and the physician had jailed the sl10 coiling catheter in place.The aneurysm successfully framed with a micrusframe 5mm x 9.7cm microcoil.This was followed by a galaxy g3 4mm x 8cm coil and then an additional galaxy 4mm x 6cm coil.The deltaxsft 3mm x 6cm coil (complaint coil) was chosen for the next coil, but it unintentionally detached during placement into the aneurysm.Approximately 2/3 of the coil was placed in the aneurysm when the physician began to reposition the coil.After a small amount of movement pulling the coil out and advancing it, the physician decided he did not have control of the coil and felt it had detached.The physician confirmed he could not remove the coil.The coil detached in the microcatheter without activating the enpower cable.It appeared to detach with minimal manipulation by the physician.He then successfully pushed the remaining approx.1.5cm of coil into the aneurysm, but it was in a position that was not completely secured with the rest of the coil mass.Ultimately, he felt the coil was well protected from the parent artery by the stent so the procedure was concluded successfully.After the case, the physician remarked that he felt some resistance when repositioning the coil, but did not feel he pulled the coil with considerable force that would detach the coil.The patient was doing well at conclusion of the procedure.The device was returned with its inner pouch.Labeling on the inner pouch matches the product documented in the complaint.The device was fully unsheathed.The embolic coil was not attached and was not returned.There were bends in the device positioning unit (dpu) core wire approximately 10 cm, 81 cm, 100 cm, 106 cm, and 139 cm from the proximal end.The detachment fiber was broken and not melted.The resistance heating (rh) coil has not received heat.The resheathing tool was undamaged.A review of manufacturing documentation associated with this lot presented no issues during the manufacturing or inspection processes related to the reported complaint.The complaint that the coil detached prematurely was confirmed.The embolic coil was not attached, the rh coil did not receive heat, and the detachment fiber was broken and not melted.The bends in the dpu core wire indicate that excessive force was applied to the device, possibly during the reported relocation of the embolic coil.The physician reported that some resistance was felt when repositioning the coil.Application of force to overcome resistance could cause the observed damage to the dpu core wire and the detachment fiber.100% of devices are inspected for condition of the detachment fiber during qc final inspection, so it is unlikely that the detachment fiber was broken when the device left the manufacturing facility.Since in the reported sequence of events the physician was able to retract and advance the embolic coil during the repositioning activity, it is most likely that the detachment fiber broke during the procedure while the embolic coil was being repositioned, and as a result of application of excessive force.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.

• Brand Name: DELTAXTRASOFT COIL
• Type of Device: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; rue girardet 29; le locle jura ; SZ
• Manufacturer Contact: joaquin kurz ; 47709 freemont blvd; freemont, CA 94538 ; 9497899383
• MDR Report Key: 6978953
• MDR Text Key: 90842461
• Report Number: 3013875781-2017-00017
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 10886704077350
• UDI-Public: (01)10886704077350(17)200630(10)S14198
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150319
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2020
• Device Catalogue Number: DLX100306
• Device Lot Number: S14198
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/22/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/27/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1