MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL G2 COMPLEX XTRASOFT COIL 3X6; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	641CX0306
Medical Device Problem Codes	Stretched (1601); Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, age, gender, weight, race, ethnicity, and medical history were not provided.Procode: krd/hcg.The phone and email address of the initial reporter are not available / reported.Physical manufacturer name: codman and shurtleff inc., dba depuy synthes products, inc.(b)(4).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 review of manufacturing documentation associated with this lot (s14414) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no non-conformances related to device manufacture or inspection.All product rejected during manufacturing was identified as scrap and properly accounted for.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 or Problem Description
The healthcare professional reported that during the coil embolization procedure, the 3mm x 6cm g2 stretch resistant complex xtrasoft coil (641cx0306 / s14414) became prematurely detached within the prowler select lpes microcatheter.The physician was able to remove both the coil and the microcatheter from the patient¿s artery without causing any damage.The reported event did result in a 15-minute delay; the procedure was reported as successfully completed without any patient adverse event or complication.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to report that the product was received by the product analysis lab on 9/5/2019.The return product is pending evaluation.A supplemental 3500a report will be submitted once the product investigation has been completed.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.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to report the investigational finding of the returned device.[conclusion]: the healthcare professional reported that during the coil embolization procedure targeting a 3.5mm x 3mm aneurysm on the anterior communicating artery (acom), the 3mm x 6cm g2 stretch resistant complex xtrasoft coil (641cx0306 / s14414) became prematurely detached at the detachment zone on the device positioning unit within the 150cm x 5cm prowler select lpes microcatheter (606s155x) while in the process of withdrawing the coil for readvancement.The physician was able to remove both the coil and the microcatheter from the patient¿s artery without causing any damage.Additional information received reported that the target vessel was not very tortuous, there was no resistance at any time during the advancement of the coil through the microcatheter.Other coils had been advanced through the same microcatheter prior to this coil; continuous flush was maintained through the microcatheter.The reported event did result in a 15-minute delay that was not considered clinically significant; the procedure was reported as successfully completed using a new microcatheter without any patient adverse event or complication.The device was returned for evaluation.The investigational finding is documented below.Investigation summary: the non-sterile 3mm x 6cm g2 stretch resistant complex xtrasoft coil and the prowler select lpes microcatheter were received contained in a pouch.X-ray image was taken, and the embolic coil was found inside the prowler microcatheter.The coil was in stretched condition.The rest of the device was not returned.A review of manufacturing documentation associated with this lot: (s14414) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no non-conformances related to device manufacture or inspection.All product rejected during manufacturing was identified as scrap and properly accounted for.The reported issue that the 3mm x 6cm g2 stretch resistant complex xtrasoft coil had become prematurely detached in the microcatheter was confirmed based on the x-ray observation of the returned device.The stretched embolic coil was inside the microcatheter.Coil stretching is known potential issue associated with the use of this device.The ifu provides proper handling instructions for the device to prevent such issue as stretching from occurring.The coil stretched condition was not originally reported in the complaint, however, it could have become stretched when the physician was attempting to withdraw the coil for readvancement.Based on the device history record review, 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 3mm x 6cm g2 stretch resistant complex xtrasoft coil left the manufacturing facility with the embolic coil in a stretched condition as was 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 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.Additional information will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).The purpose of this mdr is to include the additional event information received on 8/29/2019.[additional information]: the healthcare professional reported that during the coil embolization procedure targeting a 3.5mm x 3mm aneurysm on the anterior communicating artery (acom), the 3mm x 6cm g2 stretch resistant complex xtrasoft coil (641cx0306 / s14414) became prematurely detached at the detachment zone on the device positioning unit within the 150cm x 5cm prowler select lpes microcatheter (606s155x) while in the process of withdrawing the coil for readvancement.The physician was able to remove both the coil and the microcatheter from the patient¿s artery without causing any damage.Additional information received reported that the target vessel was not very tortuous, there was no resistance at any time during the advancement of the coil through the microcatheter.Other coils had been advanced through the same microcatheter prior to this coil; continuous flush was maintained through the microcatheter.The reported event did result in a 15-minute delay that was not considered clinically significant; the procedure was reported as successfully completed using a new microcatheter without any patient adverse event or complication.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.

• Brand Name: G2 COMPLEX XTRASOFT COIL 3X6
• 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: 8908466
• Report Number: 3008114965-2019-01108
• Device Sequence Number: 16827091
• Product Code: KRD
• UDI-Device Identifier: 10878528008948
• UDI-Public: 10878528008948
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K120686
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 07/30/2019

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: 05/31/2022
• Device Catalogue Number: 641CX0306
• Device Lot Number: S14414
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2019
• Initial Date Received by Manufacturer: 07/30/2019
• Supplement Date Received by Manufacturer: 08/29/2019; 09/05/2019; 09/23/2019
• Initial Report FDA Received Date: 08/19/2019
• Supplement Report FDA Received Date: 08/29/2019; 09/05/2019; 09/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 54 YR
• Patient Weight: 65