MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL PROWLER SELECT PLUS 150/5CM; CATHETER, CONTINUOUS FLUSH

Catalog Number 606S255X

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Vasoconstriction (2126)

Event Date 05/03/2023

Event Type  Injury  

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).Information regarding patient date of birth was not provided.A review of manufacturing documentation associated with this lot (30864986) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformances related to device manufacture or inspection.Product analysis cannot be conducted as the product was not returned for analysis.No determination of causes and possible contributing factors could be made.As such, the investigation will be closed.Vasospasm is a known potential complication associated with the use of the embotrap iii device and is listed in the instructions for use (ifu) as such.A vasospasm is a temporary tightening of the muscles in the vessel wall.This can narrow and briefly decrease or even prevent blood flow distal to the spasm and may occur when positioning/advancing the devices through the vessel/arteries.Although the pi¿s assessment regarding the relationship of event to the study device was not made available, the event occurred during the procedure; therefore, the relationship between the event and the used devices as a contributing factor cannot be ruled out entirely.Additionally, the event required intravenous medicinal treatment.Based on this information, this event meets us fda reporting criteria under 21 cfr 803 with the classification of ¿serious injury.¿ the file will be re-reviewed if additional information is received at a later date.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.This is one of 2 products involved with the reported complaint.The associated manufacturer report numbers are: 3011370111-2024-00009 and 3008114965-2024-00148.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by cerenovus, or its employees that the report constitutes an admission that the product, cerenovus, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.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 event was reported via the excellent study, the 62-year-old female patient with a history of deep vein thrombosis (dvt) and hypertension presented with a witnessed stroke on (b)(6) 2023 at 08:30 hour.The patient was presented to the treating hospital on the same day at 10:28 hour.Intravenous tissue plasminogen activator (tpa) was administered at the time of stroke presentation.The suspected origin of the embolism was ¿cardioembolic¿.The patient¿s baseline nih stroke scale (nihss) score was 16 and a modified rankin scale (mrs) score of ¿0- no symptoms.¿ on (b)(6) 2023, the patient underwent an endovascular mechanical thrombectomy procedure using a 6.5mm x 45mm embotrap iii revascularization device (et307645 / 23a108av) via a prowler select plus microcatheter (606s255x / 30864986) that targeted an occlusion in the right carotid t.The pre-pass modified thrombolysis in cerebral infarction (mtici) score was 0.The first pass resulted in an mtici score of 3, with clot retrieval in the stent retriever.During the procedure a guidewire (unspecified brand), super arrow flex® sheath (teleflex), and a flowgate2¿ balloon guide catheter (stryker) were also used.There were no reported intraoperative study device deficiencies.The patient¿s 24-hour post-procedure nihss score was 3.On (b)(6) 2023, the day of the procedure, the patient experienced the adverse event of a ¿vasospasms at the level of the cervical segment of the right arteria carotis interna with limited intraluminal, non-flow limiting intimalap.Intravenous administration of 250 mg aspégic,¿ which became known to the site on the same day and to the sponsor on (b)(6)2024.The principal investigator assessed this event as mild, not serious, and as unrelated to the large bore catheter, and as having a causal relationship to the primary surgical procedure.The relationship of event to the embotrap study device was not made available.The event required intravenous medicinal treatment.The outcome is unknown, as this information has not been updated in the clinical database, the crf, at the time of this review.The patient was discharged to another hospital on (b)(6) 2023 with a nihss score of 3 and a mrs score of ¿2-slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance.¿ on 30-jan-2024, modified information was received.Per the modified information, the following has been updated: modified information was received on 30-jan-2024.Per the modified information, the following has been updated: adverse event term: "vasospasms at the level of the cervical segment of the right arteria carotis interna with limited intraluminal, non-flow limiting intimalap.Intravenous administration of 250 mg aspégic." has been updated to ¿vasospasms at the level of the cervical segment of the right arteria carotis interna with limited intraluminal, non-flow limiting intimalap." the outcome of the adverse event has been updated from ¿blank¿ to ¿recovered / resolved.¿ the relationship to the embotrap has been updated from ¿blank¿ to ¿not related.¿ the severity has been updated from ¿mild¿ to ¿moderate.¿ the end date has been updated from ¿blank¿ to ¿03-may-2023.¿.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to include the additional event information received on 13-feb-2024.[additional information]: on 13-feb-2024, additional information was received.Per the information, there were no device performance issue related to the embotrap iii device, the prowler select plus microcatheter.¿vasospasms was indeed at location where instrument was used.This happens frequently and this disappears after the procedure.¿ this is one of 2 products involved with the reported complaint.The associated manufacturer report numbers are: 3011370111-2024-00009 and 3008114965-2024-00148.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: PROWLER SELECT PLUS 150/5CM
• Type of Device: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel CH-24 00; SZ CH-2400
• Manufacturer (Section G): CERENOVUS INC. (JUAREZ); circuito interior norte #1820; parque industrial salvarcar; juarez chihuahua 32574 ; MX 32574
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 303552-689
• MDR Report Key: 18691997
• MDR Text Key: 335187591
• Report Number: 3008114965-2024-00148
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K021591
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 606S255X
• Device Lot Number: 30864986
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/13/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/07/2022
• 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
• Treatment: EMBOTRAP III 6.5 MM X 45 MM; FLOWGATE2¿ BALLOON GUIDE CATHETER (STRYKER); GUIDEWIRE (UNSPECIFIED BRAND); SUPER ARROW FLEX® SHEATH (TELEFLEX)
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Weight: 63 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White