MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL PROWLER SEL PLUS 150/5CM 45TIP; CATHETER, CONTINUOUS FLUSH

Model Number	606-S255FX
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/17/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The healthcare professional reported that during the procedure, the 4.0mm dia x 23mm enterprise®2 stent with no tip (enf402300 / 11176793) became stuck in the proximal section of the 150cm x 5cm prowler select plus microcatheter (606s255fx / 30465450) during the attempt to insert it into the microcatheter through the y connector.The operator tried to pull the enterprise stent but due to the strong resistance, the enterprise stent could not be removed from the microcatheter.There was no report of any procedure delay due to the reported issue; it was reported that the procedure was successfully completed without any patient adverse event or complication.
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.The name, phone and email address of the initial reporter are not available / 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.A review of manufacturing documentation associated with this lot (30465450) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformance's related to device manufacture or inspection.All product rejected during manufacturing was identified as scrap and properly accounted for.This is one of 2 products involved with the reported complaint.The associated manufacturer report numbers are: 3008114965-2021-00618.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.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 include the additional event information received on 17-dec-2021.[conclusion / additional information]: the healthcare professional reported that during the procedure, the 4.0mm dia x 23mm enterprise®2 stent with no tip (enf402300 / 11176793) became stuck in the proximal section of the 150cm x 5cm prowler select plus microcatheter (606s255fx / 30465450) during the attempt to insert it into the microcatheter through the y connector.The operator tried to pull the enterprise stent but due to the strong resistance, the enterprise stent could not be removed from the microcatheter.There was no report of any procedure delay due to the reported issue; it was reported that the procedure was successfully completed without any patient adverse event or complication.On 17 dec 2021, additional information was received.The information received indicated that continuous flush had been maintained through the microcatheter during the aneurysm coiling procedure.There were no kinks nor bends in the microcatheter that may have contributed to the reported event.No damage was noted on the microcatheter when it was removed.The stent component of the enterprise was still on the delivery wire when it was removed from the patient; no damage was noted on the stent component.The device moved forward out of the hub of the microcatheter and it was verified that the introducer was fully seated and secured in the hub.Nothing unusual was noted on the system prior to use.The devices were used in accordance with the instructions for use (ifu).The stent and microcatheter were both pulled from the patient.Another the 4.0mm dia x 23mm enterprise®2 stent with no tip (enf402300) with another unspecified microcatheter to complete the procedure.It was also reported that the product is not available for return.Based on complaint information, the device is not available to be returned for analysis.A review of manufacturing documentation associated with this lot (30465450) 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 device is not available to be returned for analysis and therefore, no further investigation can be performed at this time.As a result, we are closing this investigation.If the complaint device is received in the future, we will reopen the complaint and perform the investigation as appropriate.With the information available and without the products available for analyses, the reported complaint could not be confirmed.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 information provided and without the return of the complaint sample; however, it is possible that clinical and procedural factors, including device manipulation / interaction, aneurysm size / vessel characteristics, device selection, and the concomitant microcatheter, may have contributed to the reported issue.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: 3008114965-2021-00618 and 3008114965-2021-00619.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 SEL PLUS 150/5CM 45TIP
• 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 ; 949789-8687
• MDR Report Key: 13020463
• Report Number: 3008114965-2021-00619
• Device Sequence Number: 17344253
• Product Code: KRA
• UDI-Device Identifier: 10886704028857
• UDI-Public: 10886704028857
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/17/2021

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 Model Number: 606-S255FX
• Device Catalogue Number: 606S255FX
• Device Lot Number: 30465450
• 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: 11/30/2021
• Supplement Date Received by Manufacturer: 12/17/2021
• Initial Report FDA Received Date: 12/16/2021
• Supplement Report FDA Received Date: 12/17/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: ENTERPRISE2 4MMX23MM NO TIP
• Patient Sex: Unknown