MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL DELTAPLUSH COIL, 10 SYS 2X4; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	DPL100204-20
Medical Device Problem Code	Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/06/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Procode: krd/hcg.The device is available to be returned for evaluation and testing.However, it has not been received to date as indicated as ¿other¿ in this section as the reason for non-evaluation.If the device returns, a device investigation will be performed.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
As reported by the field, during a coil embolization, a deltaplush coil, 10 sys 2x4 coil (dpl10020420, l11248) became stretched while in use.There was no patient injury reported.
Additional Manufacturer Narrative
Product complaint#: (b)(4).Section b5: additional information was received indicating that the location of the damage on the device was not available.The device becoming stretched occurred during advancement.Prior to this coil, other coils had advanced through the same microcatheter (mc).No excessive force was applied to the device.The device was removed from the patient without additional intervention.It was not necessary to remove concomitant devices with the complaint device.The procedure was completed by replacing another spec of product to complete the surgery.Adequate flush was maintained through the devices.The event did not prolong the procedure.A deltaplush coil, 10 sys 3x4 (dpl100304-20/ lot#: s14373) and a deltaplush coil, 10 sys 2x2 (dpl100202-20/ lot#: l15720) were also used in the case.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.Complaint conclusion: as reported by the field, during a coil embolization, a deltaplush coil, 10 sys 2x4 coil (dpl10020420, l11248) became stretched while in use.There was no patient injury reported.Additional information was received indicating that the location of the damage on the device was not available.The device becoming stretched occurred during advancement.Prior to this coil, other coils had advanced through the same microcatheter (mc).No excessive force was applied to the device.The device was removed from the patient without additional intervention.It was not necessary to remove concomitant devices with the compliant device.The procedure was completed by replacing another spec of product to complete the surgery.Adequate flush was maintained through the devices.The event did not prolong the procedure.A deltaplush coil, 10 sys 3x4 (dpl100304-20/ lot#: s14373) and a deltaplush coil, 10 sys 2x2 (dpl100202-20/ lot#: l15720) were also used in the case.A non-sterile unit deltaplush coil, 10 sys 2x4 was received inside of a pouch.The device was inspected, and it was found the dpu with a kink condition at the strain relief section.No other damages or anomalies were observed during the visual inspection.The embolic coil was inspected under a microscope and it was found with a stretch condition.Mre review: a manufacturing record evaluation was performed for the finished device l11248 number, and no non-conformances related to the reported complaint condition were identified.The complaint reported by the customer ¿coil - unraveled / stretched-during use¿ was confirmed, during the microscopic inspection, the embolic coil was found with a stretch condition.The kinked condition noted on the dpu and the stretch condition noted on the embolic coil could be related with the customer¿s complaint and appears to might have been caused by excessive force and handling being applied to the device however none of those can be conclusively determined.Neither the analysis nor the mre suggests that the failure reported by the customer could be related to the manufacturing process.Assignment of root cause for the event remains speculative and inconclusive, based on the limited information provided and the evidence presented by the returned device; however, it is possible that clinical and procedural factors, including device manipulation and device interaction, may have contributed to the reported failure and damages on the returned system.An embolic coil becomes stretched when an excessive pull force is applied to the device.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: DELTAPLUSH COIL, 10 SYS 2X4
• 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: 10567162
• Report Number: 3008114965-2020-00420
• Device Sequence Number: 19509230
• Product Code: KRD
• UDI-Device Identifier: 00878528008064
• UDI-Public: 00878528008064
• Combination Product (Y/N): N
• PMA/510(K) Number: K083646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/31/2020

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: 12/31/2022
• Device Model Number: DPL100204-20
• Device Catalogue Number: DPL10020420
• Device Lot Number: L11248
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2020
• Initial Date Received by Manufacturer: 08/31/2020
• Supplement Date Received by Manufacturer: 10/12/2020
• Initial Report FDA Received Date: 09/22/2020
• Supplement Report FDA Received Date: 11/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1