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

Model Number DLX100153

Device Problems Fracture (1260); Stretched (1601)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/20/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Procode is krd/hcg.Physical manufacturer name: codman and shurtleff inc., dba depuy synthes products, inc.((b)(4)).[conclusion]: the healthcare professional reported that during the coil embolization procedure, the 150cm x 5cm 90 deg tip prowler select lpes was used to deliver different coils.The two 1.5mm x 3cm deltaxsft 10 coils (dlx100153 / l16148) and (dlx100153 / l16826) could not be advanced through the microcatheter.Resistance was felt at the proximal end of the microcatheter shaft.There was no report of any physical material obstructing the microcatheter.It was reported that other coils were successfully introduced and advanced through the same microcatheter both before the reported issue with these two coils and after the reported issue.There was no report of any patient adverse event or complication.The device was returned for evaluation and analysis.The investigational finding is documented below.Investigation summary: the non-sterile 1.5mm x 3cm deltaxsft 10 coil from lot l16148 was returned and received contained in a pouch.Visual inspection was performed, no damage was noted on the device upon the visual inspection.The device underwent a microscopic inspection for the condition of the embolic coil.The embolic coil was observed stretched, broken and stuck inside the introducer.The complaint documented that the 1.5mm x 3cm deltaxsft 10 coil could not be advanced through the microcatheter.The condition of the returned device precluded it from undergoing functional evaluation.The observed stretched, broken condition of the embolic coil and it being stuck in the introducer may have been contributing factors for the reported issue of it not being able to be advanced through the microcatheter.The likely cause of the observed condition of the coil is forced, though it cannot be conclusively determined.A review of manufacturing documentation associated with this lot (l16148) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformances related to device manufacture or inspection.All product rejected during manufacturing was identified as scrap and properly accounted for.Conditions such as coil stretching, and coil being broken are known potential issues associated with the use of the device.The instruction for use provides proper handling instructions for the device to prevent issues such as stretching and broken coil from occurring.The stretched and broken condition of the coil were not originally reported with the complaint.The likely cause of the stretched and broken condition observed on the coil is applied force, though the exact cause cannot be conclusively determined.Based on the review of the manufacturing documentation, 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 left the manufacturing facility with the embolic coil stuck inside the introducer in stretched and broken condition as observed on the embolic coil of the returned device.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 stretched condition observed on the returned coil was related to a manufacturing or design issue, no corrective actions will be taken at this time.This is one of two products involved with the reported complaint.The associated manufacturer report number is: 3008114965-2020-00095.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 Description

The healthcare professional reported that during the coil embolization procedure, the 150cm x 5cm 90 deg tip prowler select lpes was used to deliver different coils.The two 1.5mm x 3cm deltaxsft 10 coils (dlx100153 / l16148) and (dlx100153 / l16826) could not be advanced through the microcatheter.Resistance was felt at the proximal end of the microcatheter shaft.There was no report of any physical material obstructing the microcatheter.It was reported that other coils were successfully introduced and advanced through the same microcatheter both before the reported issue with these two coils and after the reported issue.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 stuck inside the introducer in stretched and broken condition.Based on the product analysis 4/3/2020, this event has been deemed mdr reportable as a ¿malfunction.¿.

• Brand Name: DELTAXSFT10 1.5MM X 3CM
• Type of Device: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel CH-24 00; SZ CH-2400
• Manufacturer (Section G): CODMAN & SHURTLEFF, INC. (FREMONT); 47709 fremont blvd; fremont CA 94538
• Manufacturer Contact: gabriel alfageme ; 31 technology drive; irvine, CA 92618 ; 949789-868
• MDR Report Key: 9931698
• MDR Text Key: 195896202
• Report Number: 3008114965-2020-00096
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 10886704077268
• UDI-Public: 10886704077268
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K150319
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2022
• Device Model Number: DLX100153
• Device Catalogue Number: DLX100153
• Device Lot Number: L16148
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/03/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/10/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1