MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL PRESHAPED PROWLER10 45TIP 2MRK; CATHETER, CONTINUOUS FLUSH

Model Number 606-051FX

Device Problem Physical Resistance/Sticking (4012)

Patient Problem Hemorrhage, Subarachnoid (1893)

Event Date 02/28/2020

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Based on additional information received on 15-apr-2020, the complaint meets regulatory reporting criteria.(b)(6).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.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.The product has been returned for evaluation and testing; however, the engineering evaluation has not been completed.Additional information will be submitted within 30 days of receipt.

Event Description

A report from the field indicated that shortly before a 2x4 hypersoft (microvention) coil was completely inside the aneurysm and about to be detached, the coil could neither be pushed nor pulled.The prowler10 45tip 2mrk (606051fx/17751954) pre-shaped microcatheter was ¿stretched so the coil torn through¿.The coil was damaged ¿at the joint between the coil itself and the pusher wire¿.Part of the coil remained in the catheter and the rest of the coil in the patient.The ¿stretched¿ coil was ¿catched¿ in the long sheath using a stent retriever.There was no report of adverse outcome to the patient.A 3x10 hypersoft (microvention) coil was used prior to the complaint coil and there were no issues encountered during advancement or detachment.The microcatheter had not been re-shaped after removal from the packaging and the device had not been inserted through a stopcock instead of a hemostasis valve.The physician did not have ¿any problems while probing the vessels with microwire and microcatheter¿.The complaint microcatheter and part of the 2x4 hypersoft coil will be returned for evaluation.No further information was provided.Additional information received on 05-may-2020 indicated that the target aneurysm was located at the anterior communicating artery.Reportedly, there was an adequate and continuous flush maintained through the devices and excessive force was not applied at any time.The procedure was completed with ¿aneurysm remainder (rest) with coil in the carrier vessel¿.The patient experienced a subarachnoid hemorrhage (hunt & hess grade 1), but the exact timing in relation to the reported event was not reported.

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: a report from the field indicated that shortly before a 2x4 hypersoft (microvention) coil was completely inside the aneurysm and about to be detached, the coil could neither be pushed nor pulled.The prowler10 45tip 2mrk (606051fx/17751954) pre-shaped microcatheter was ¿stretched so the coil torn through¿.The coil was damaged ¿at the joint between the coil itself and the pusher wire¿.Part of the coil remained in the catheter and the rest of the coil in the patient.The ¿stretched¿ coil was ¿catched¿ in the long sheath using a stent retriever.There was no report of adverse outcome to the patient.A 3x10 hypersoft (microvention) coil was used prior to the complaint coil and there were no issues encountered during advancement or detachment.The microcatheter had not been re-shaped after removal from the packaging and the device had not been inserted through a stopcock instead of a hemostasis valve.The physician did not have ¿any problems while probing the vessels with microwire and microcatheter¿.Additional information received on 05-may-2020 indicated that the target aneurysm was located at the anterior communicating artery.Reportedly, there was an adequate and continuous flush maintained through the devices and excessive force was not applied at any time.The procedure was completed with ¿aneurysm remainder (rest) with coil in the carrier vessel¿.The patient experienced a subarachnoid hemorrhage (hunt & hess grade 1), but the exact timing in relation to the reported event was not reported.No further information was provided.One non-sterile preshaped prowler10 45tip 2mrk unit was received inside of a pouch.The device was visually inspected, the body of the device was found with several kinks and compressed, also a slightly curvy condition could be noted.Then a microscopic inspection was performed, and an unknown coil was found protruding from the distal tip of the device no other damages were observed.The id and od from the micro-catheter were measured and were found within specification.A manufacturing record evaluation was performed for the finished device 17751954 number, and no non-conformances related to the reported complaint condition were identified the complaint reported by the customer ¿catheter (body/shaft)¿ unraveled/stretched¿ was not able to be confirmed.The stretched condition was not found on the device.The complaint reported by the customer ¿catheter (body/shaft)¿ obstructed-in patient with loss of mc cerebral target position¿ could not be evaluated because it is specific to the patient and procedure at the time of occurrence and cannot be replicated in the lab.However, the compressed condition may have contributed to the failure since the coil was found stuck inside in this section, the damage of compression may have been caused by use of excessive force and handling in the device and because of this we can confirm the complaint.Neither the analysis nor the mre suggest that the failure reported could be related to the manufacturing process.Catheter obstructed and unraveled/stretched necessitating additional intervention and subarachnoid hemorrhage are known potential complications associated with the prowler microcatheter.Per the prowler microcatheter instructions for use (ifu), if strong resistance is met during manipulation, discontinue the procedure and determine the cause of resistance before proceeding.If the cause of resistance cannot be determined, withdraw the catheter and guidewire as a system.The root cause of the event cannot be determined based on the information available for review; however, according to the microplex coil system (mcs) (hypersoft 3d complex) ifu, the mcs should be delivered with a wire-reinforced microcatheter with the specified minimum internal diameter (id) of 0.0165¿.The labeled id of the prowler10 is 0.015¿.Assignment of root cause for the event remains speculative and inconclusive; however, it appears that circumstances of the procedure may have contributed rather than the design or manufacture of the device.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 to identify statistical signals for consideration of further correction action.Since there was no evidence to suggest the events were related to a manufacturing or design issue, no corrective actions will be taken at this time.

• Brand Name: PRESHAPED PROWLER10 45TIP 2MRK
• Type of Device: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel CH-24 00; SZ CH-2400
• MDR Report Key: 10028646
• MDR Text Key: 194623116
• Report Number: 3008114965-2020-00158
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 10886704028529
• UDI-Public: 10886704028529
• Combination Product (y/n): N
• PMA/PMN Number: K003925
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 03/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2020
• Device Model Number: 606-051FX
• Device Catalogue Number: 606051FX
• Device Lot Number: 17751954
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2020
• Date Manufacturer Received: 05/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 2MM X 4CM HYPERSOFT COIL (MICROVENTION); 3X10 HYPERSOFT (MICROVENTION)
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 60 YR
• Patient Weight: 80