MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL PROWLER SELECT LPES; CATHETER, CONTINUOUS FLUSH

Catalog Number	606S155X
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/11/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The healthcare professional reported that during an endovascular embolization procedure, there was resistance while pushing two 9mm x 30cm orbit galaxy complex frame coils (640cr0930) both from lot 30957434 in the microcatheter.The coils were removed.The procedure was delayed by 10 minutes; the procedure was successfully completed.There was no report of any negative patient impact.On 26-dec-2023, additional information was received.The information indicated that the target aneurysm was an anterior communicating artery (acom) aneurysm.There were no remarkable anatomical / vessel characteristics such as vessel calcification and/or tortuosity.The microcatheter used was a prowler select lpes microcatheter (606s155x / 31041133).Per the additional information, the reported resistance as first felt during advancement of the device inside the concomitant microcatheter at mid-shaft.A continuous flush had been maintained through the microcatheter during the procedure.Prior to the reported resistance, a 10mm x 30cm orbit galaxy complex fill coil (640cf1030 / 30856382) was successfully used with the microcatheter.The microcatheter was removed when the resistance was encountered.The introducer on both coils were flushed until liquid was visible at the distal end of the slit in the clear tube.The introducers were firmly installed into the microcatheter hub and locked with the rotating hemostasis valve (rhv) during the device advancement.The devices did not appear damaged.The procedure was successfully completed; the physician did not consider the 10-minute delay to be clinically significant.On 03-jan-2024, additional information was received.Per the information, the two orbit galaxy were replaced with 10mm x 30cm orbit galaxy complex fill coil (640cf1030).The information also indicated that the prowler select lpes microcatheter is not available for return.Based on the additional information received on 26-dec-2023, the event has been deemed usfda reportable under 21 cfr 803 with a classification of ¿malfunction.¿.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, age, gender, weight, race, and ethnicity were not provided.Section e.1: the initial reporter phone and email address are not available / reported.Section e.1: initial reporter address line 1: (b)(4).Based on complaint information, the device is not available to be returned for analysis.A review of manufacturing documentation associated with this lot (31041133) 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.With the information available and without the complaint product available to be returned for analysis, the reported product issue documented in the complaint cannot be confirmed through functional evaluation and analysis.Based on the manufacturing documentation review, there is no indication that the event is related to the device manufacturing process.Assignment of root cause for the event remains speculative and inconclusive, based on the limited information provided and without the return of the complaint sample; however, it is possible that clinical and procedural factors, including device manipulation / interaction may have contributed to the reported failure.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 3 products involved with the reported complaint.The associated manufacturer report numbers are: 3008114965-2023-00980, 3008114965-2023-00981.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.Missing information from this report is identified as blank; this information was not provided in the reported event or available at the time of report submission.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 LPES
• Common Device Name: 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 ; 303552-6892
• MDR Report Key: 18509082
• Report Number: 3008114965-2023-00982
• Device Sequence Number: 7811331
• Product Code: KRA
• UDI-Device Identifier: 10886704028802
• UDI-Public: 10886704028802
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K021591
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/12/2024

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: 04/30/2026
• Device Catalogue Number: 606S155X
• Device Lot Number: 31041133
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/26/2023
• Initial Report FDA Received Date: 01/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/11/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: OG TDL CMPLX FILL COIL 10X30; OG TDL CMPLX FRAME COIL 9X30; OG TDL CMPLX FRAME COIL 9X30
• Patient Sex: Unknown