MAUDE Adverse Event Report: REFER TO SECTION H10 DELTAXSFT10 2.5MM X 4CM; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	DLX100254
Medical Device Problem Codes	Kinked (1339); Physical Resistance (2578)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/05/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4) based on the analysis findings made available on 2/5/2018, this product event has been deemed mdr reportable.Information regarding patient age, weight, medical history, race, and ethnicity were not provided.Procode: krd/hcg.(b)(4).Concomitant med products: deltaxsft10 (dlx100206, c40691), deltaxsft10 (dlx100204, c40595), carnelian marvel microcatheter (tokai medical products), and dcb02 detachment control box initial reporter - the customer contact information, including e-mail address, phone, and fax number was not provided.(b)(4).Complaint conclusion: as reported by a healthcare professional, during a pre-tumor coil embolization of a left middle meningeal artery (mma) aneurysm, the physician attempted to deploy the deltaxsft10 2 mm x 6 cm (dlx100206/c40691) and deltaxsft10 2 mm x 4 cm (dlx100204/c40595) thermo-mechanical coils in saline prior to inserting into the microcatheter; however, the coils came out of the side of the sheath instead of the tip.The coils were replaced with a deltaxsft10 2.5 mm x 4 cm (dlx100254, c40597) thermo-mechanical coil.The coil was inserted into the microcatheter without any issue, but strong resistance was felt when the coil was placed.The coil was not able to be pushed or pulled.The coil was subsequently replaced with a galaxy coil.There was no report of patient injury.Due to these two events, the surgery was delayed a total of 40 minutes.The embolization was started for the nutrient vessels of the lt-mma.The patient¿s vessel was mildly torturous and not calcified.A carnelian marvel (tokai medical products) microcatheter and dcb02 detachment control box were also used for this case.The products were stored per labeling instructions.The procedure was conducted in accordance with the instructions for use (ifu) and a constant flush was maintained.No visible product damage was noted prior to the event.There was no damage noted to the coil or introducer.No unintended detachment was observed in the vessel or in the microcatheter.Reportedly, excessive force was not applied during preparation.No further information was provided.The deltaxsft10 2.5 mm x 4 cm (c40597) was returned with its inner pouch.Labeling on the inner pouch matched the product documented in the complaint.The device was returned inserted through a rotating hemostatic valve (rhv) and a non-cerenovus microcatheter.A loop of embolic coil exited the distal end of the microcatheter.The distal end of the embolic coil remained inside the microcatheter.The device was completely unsheathed, and the resheathing tool was advanced all the way to the green introducer.There was a bend in the device positioning unit (dpu) core wire distal to the end of the green introducer.The ball tip of the embolic coil was located inside the microcatheter.The visible section of embolic coil was kinked.The v-notch of the resheathing tool was undamaged.An attempt was made to advance the embolic coil further out of the microcatheter.The device could not be advanced or retracted.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 device is impeded in the microcatheter was confirmed.The embolic coil was fully introduced into the microcatheter and exited the distal end of the microcatheter.The device could not advance or retract from its current position.The distal tip of the embolic coil was located inside the microcatheter, and a more proximal length of embolic coil has been pushed past the distal tip.The doubled mass of embolic coil was lodged in the tip of the microcatheter and could not be moved.While the exact circumstances are unknown, the loop of embolic coil exiting the microcatheter indicates that excessive force was applied to the device, possibly in an attempt to free the distal end of the embolic coil from the circumstance that impeded it initially.The cause of the initial resistance of the embolic coil cannot be determined from the returned device.Pushing the loop of embolic coil past the coil¿s distal end is the most likely cause of the kinks in the visible section of embolic coil.While the exact cause of the event could not be definitively determined; there are circumstances of the procedure that may have contributed to the reported event.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.This is one of three products involved with the reported complaint and the associated manufacturer report numbers are 3008114965-2018-00527, and 3008114965-2018-00528.
Event or Problem Description
As reported by a healthcare professional, during a pre-tumor coil embolization of a left middle meningeal artery (mma) aneurysm, the physician attempted to deploy the deltaxsft10 2 mm x 6 cm (dlx100206/c40691) and deltaxsft10 2 mm x 4 cm (dlx100204/c40595) thermo-mechanical coils in saline prior to inserting into the microcatheter; however, the coils came out of the side of the sheath instead of the tip.The coils were replaced with a deltaxsft10 2.5 mm x 4 cm (dlx100254, c40597) thermo-mechanical coil.The coil was inserted into the microcatheter without any issue, but strong resistance was felt when the coil was placed.The coil was not able to be pushed or pulled in the coil introducer.The coil was subsequently replaced with a galaxy coil.There was no report of patient injury.Due to these two events, the procedure was delayed 40 minutes.The embolization was started for the nutrient vessels of the lt-mma.The patient¿s vessel was mildly torturous and not calcified.A carnelian marvel (tokai medical products) microcatheter and dcb02 detachment control box were also used for this procedure.The products were stored per labeling instructions.The procedure was conducted in accordance with the instructions for use (ifu) and a constant flush was maintained.No visible product damage was noted prior to the event.There was no damage noted to the coil or introducer.No unintended detachment was observed in the vessel or in the microcatheter.Reportedly, excessive force was not applied during preparation.The products will be returned investigation.No further information was provided.

• Brand Name: DELTAXSFT10 2.5MM X 4CM
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): REFER TO SECTION H10; 47709 fremont blvd; fremont CA 94538
• MDR Report Key: 7296489
• Report Number: 3008114965-2018-00529
• Device Sequence Number: 19427693
• Product Code: KRD
• UDI-Device Identifier: 10886704077275
• UDI-Public: 10886704077275
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K150319
• 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
• Report Date (Section B): 12/05/2017

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: 01/31/2019
• Device Catalogue Number: DLX100254
• Device Lot Number: C40597
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2017
• Initial Date Received by Manufacturer: 02/05/2018
• Initial Report FDA Received Date: 02/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1