MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL OG TDL CMPLX FILL COIL 4X12; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	640CF0412
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/13/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).Information regarding patient date of birth, weight, and medical history were not provided.Procode is 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 review of manufacturing documentation associated with this lot (30201509) 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.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 targeting an aneurysm on the posterior communicating artery (pcoa) in the (b)(6) female patient, the 4mm x 12cm orbit galaxy complex fill coil (640cf0412 / 30201509) could not advance in the sl-10® microcatheter (stryker); the coil encountered resistance after it was introduced into the microcatheter, to a small portion of the microcatheter where it could not longer be advanced.The physician withdrew the coil and the concomitant microcatheter from the patient.It was reported that continuous flus had been maintained through the microcatheter.There was no damage to the coil or the coil delivery system when it was removed with the microcatheter from the patient.An orbit galaxy complex xtrasoft coil (640cx0306 / 30212140) was used as replacement for the complaint coil and it was delivered and implanted with the original microcatheter.The reported issue resulted in a half an hour procedural delay that the physician deemed clinically significant because it increases the risk of aneurysm rupture and prolong surgery time makes the procedure more difficult for the physician.There was no report of any patient adverse event or complication.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: pc-(b)(4).The purpose of this mdr submission is to report that the product was received by the product analysis lab on 3/20/2020, and to report the investigational finding based on the function evaluation that was performed on the returned device.[conclusion]: the healthcare professional reported that during the coil embolization procedure targeting an aneurysm on the posterior communicating artery (pcoa) in the 55-year-old female patient, the 4mm x 12cm orbit galaxy complex fill coil (640cf0412 / 30201509) could not advance in the sl-10® microcatheter (stryker); the coil encountered resistance after it was introduced into the microcatheter, to a small portion of the microcatheter where it could no longer be advanced.The physician withdrew the coil and the concomitant microcatheter from the patient.It was reported that continuous flus had been maintained through the microcatheter.There was no damage to the coil or the coil delivery system when it was removed with the microcatheter from the patient.An orbit galaxy complex xtrasoft coil (640cx0306 / 30212140) was used as replacement for the complaint coil and it was delivered and implanted with the original microcatheter.The reported issue resulted in a half an hour procedural delay that the physician deemed clinically significant because it increases the risk of aneurysm rupture and prolong surgery time makes the procedure more difficult for the physician.There was no report of any patient adverse event or complication.The product was returned for evaluation.The investigational finding is documented below.Investigation summary: the non-sterile 4mm x 12cm orbit galaxy complex fill coil was received contained in a pouch.Visual inspection was performed; no damages were noted on the device during the visual inspection.A microscopic inspection was performed.The embolic coil was observed in good condition.No other damage was observed.Functional analysis: the concomitant sl-10® microcatheter (stryker) was not returned.A lab sample prowler select plus microcatheter was flushed using a lab sample syringe.After the microcatheter was flushed, the 4mm x 12cm orbit galaxy complex fill coil was introduced into the microcatheter and advanced through without any resistance friction encountered.The complaint documented that during the coil embolization procedure targeting an aneurysm on the pcoa, the 4mm x 12cm orbit galaxy complex fill coil could not advance in the sl-10® microcatheter (stryker).It was reported that the coil encountered resistance after it was introduced into a small portion of the microcatheter and could not advance further.The reported issue was not confirmed based on the functional testing performed on the returned device.The returned coil was successfully introduced into the lab sample microcatheter and advanced without any resistance friction encountered.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 of failure to detach was related to a manufacturing or design issue, no corrective actions will be taken at this time.Updated sections: d.10, g.4, g.7, h.2, h.3, h.6, and h.10.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: OG TDL CMPLX FILL COIL 4X12
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle MA CH-24 00; SZ CH-2400
• MDR Report Key: 9844587
• Report Number: 1226348-2020-00014
• Device Sequence Number: 19023840
• Product Code: KRD
• UDI-Device Identifier: 10886704030270
• UDI-Public: 10886704030270
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K093973
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2020

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: 02/28/2021
• Device Model Number: 640CF0412
• Device Catalogue Number: 640CF0412
• Device Lot Number: 30201509
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2020
• Initial Date Received by Manufacturer: 02/25/2020
• Supplement Date Received by Manufacturer: 03/20/2020
• Initial Report FDA Received Date: 03/17/2020
• Supplement Report FDA Received Date: 03/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SL-10® MICROCATHETER (STRYKER)
• Patient Age: 55 YR