MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL PROWLER SELECT LPES 45 DEG TIP; CATHETER, CONTINUOUS FLUSH

Model Number	606-S155FX
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.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.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 company is seeking this information through the event investigation.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.This is one of two products involved with the complaint.
Event or Problem Description
As reported by the field, during an intracranial coil embolization, a galaxy g3 xsft coil 4mm x 6cm (glx120406, 30513170) could not easily be introduced into a prowler select lpes 45 deg tip microcatheter (606-s155fx, 30422138).When pulling the coil back to introduce again into the microcatheter (mc), the coil became stretched.The intracranial procedure was finished successfully with a new prowler select and a new coil.The surgery was delayed due to the reported event.The procedure was successfully completed.
Additional Manufacturer Narrative
Product complaint # (b)(4).The following information was inadvertently omitted on the follow up report 1 mwr-04042022-0001160762.Section h6.Type of investigation: device not returned (b17).
Additional Manufacturer Narrative
Product complaint # (b)(4).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 an intracranial coil embolization, a galaxy g3 xsft coil 4mm x 6cm (glx120406, 30513170) could not easily be introduced into a prowler select lpes 45 deg tip microcatheter (606-s155fx, 30422138).When pulling the coil back to introduce again into the microcatheter (mc), the coil became stretched.The intracranial procedure was finished successfully with a new prowler select and a new coil.The surgery was delayed due to the reported event.The procedure was successfully completed.No additional information is available.The device was discarded; therefore, no further investigation can be performed.A manufacturing record evaluation was performed for the finished device 30422138 number, and no non-conformances related to the malfunction were identified.Resistance/friction-inner lumen with loss of mc cerebral target position is a known potential procedural complication associated with the use of this prowler select.With the information available and without the product available for analysis, the reported customer complaint could not be confirmed.Based on the manufacturing record evaluation (mre), there is no indication that the event is related to the device manufacturing process.The instructions for use (ifu) warns to never advance or withdraw an intraluminal device against resistance.Movement or force of catheter or guide wire against resistance could dislodge a clot, perforate a vessel wall, or severely damage the catheter and/or guide wire.Assignment of root cause for the event remains speculative and inconclusive, based on the limited information provided and without the return of the complaint devices; however, it is possible that clinical and procedural factors, including device manipulation / interaction, aneurysm size and vessel characteristics and device selection may have contributed to the reported issue.As part of the cerenovus quality process, all devices are manufactured, inspected, and released to approved specifications.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: PROWLER SELECT LPES 45 DEG TIP
• 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): CODMAN & SHURTLEFF, INC. (JUAREZ); circuito interior norte #1820; parque industrial salvarcar; juarez chihuahua 32574 ; MX 32574
• Manufacturer Contact: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 13441828
• Report Number: 3008114965-2022-00076
• Device Sequence Number: 2084229
• Product Code: KRA
• UDI-Device Identifier: 10886704028772
• UDI-Public: 10886704028772
• Combination Product (Y/N): N
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/12/2022

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: 06/30/2023
• Device Model Number: 606-S155FX
• Device Catalogue Number: 606S155FX
• Device Lot Number: 30422138
• 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: 01/19/2022
• Supplement Date Received by Manufacturer: 04/04/2022; 04/12/2022
• Initial Report FDA Received Date: 02/03/2022
• Supplement Report FDA Received Date: 04/05/2022; 04/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/28/2020
• 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: GALAXY G3 XSFT 4MM X 6CM
• Patient Sex: Unknown