MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL 132CM LARGE BORE 71 CATHETER; CATHETER, ASPIRATION CATHETER

Catalog Number	IC71132UG
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/23/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, weight, race, and ethnicity were not provided.The complaint product was returned and received for evaluation and analysis.The investigation is documented below.Investigation summary: a non-sterile embovac large bore 71 catheter embovac large bore 71 catheter was received contained in the decontamination pouch.Visual inspection was performed.The presence of the hydrophilic coating was confirmed.The distal tip was found flattened and coiled, and the braided wire was found to be compressed and slightly stretched from 116.5cm until the tip.Also, one fractured condition was noted in the catheter at 17.50cm, the internal braided wires were exposed.These measurements were taken from the proximal end of the catheter.No other damages were observed.Further inspection under microscopic magnification revealed that the internal braided wires were exposed as a result of the stretching.The device was then flushed with a lab-sample syringe, and no water leakage was observed on the stretched portion.The inner diameter (id) and outer diameter (od) of the device were confirmed to be within specifications.A review of manufacturing documentation associated with this lot (31117548) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformances related to device manufacture or inspection.The issue reported regarding the damaged condition of the tip of the catheter was confirmed based on the findings mentioned above.The patient's anatomy was reported as difficult, this condition and other factors not described in the complaint such as device manipulation, and operator¿s technique, may have contributed to the issue encountered.According to the risk documentation, anatomical tortuosity, no inspection, and continuing to use a damaged catheter are potential causes of failure for catheter damage.With the limited information available, a conclusive cause cannot be determined, however, given the broad sequence of events, there is no indication that the issue reported in the complaint is related to a manufacturing issue.The fractured condition of the catheter was not originally reported, indicating that this condition could have been the result of the post-handling manipulation of the device; therefore, this condition is not considered related to the issue reported.As part of the cerenovus quality process, all devices are manufactured, inspected, and released to approved specifications.It should be noted that product failure could be caused by multiple factors.The instructions for use (ifu) contains the following cautions: ¿ do not advance or withdraw an intravascular device against resistance until the cause of the resistance is determined by fluoroscopy.Movement of the device against resistance could dislodge a clot, perforate a vessel wall, or damage the device.¿ exercise care in handling the large bore catheter to reduce the chance of accidental damage.Based on the manufacturing documentation review, there is no indication that the event is related to the device manufacturing process.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.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 or Problem Description
The healthcare professional reported that the 67-year-old female patient presented with a left m1 stroke underwent a thrombectomy procedure.During the procedure an embovac large bore 71 catheter (ic71132ug / 31117548) was used with a 4mm x 41mm trevo nxt¿ stent retriever (stryker) and the tip of the embovac lbc was damaged after one pass.It was replaced with another embovac large bore 71 catheter (ic71132ug) from the same lot (31117548) which was also damaged after a second pass with the stent retriever.Two apro¿* 70 aspiration catheters (medtronic) were used either damaged or failed, but another (a third) embovac large bore 71 catheter was used successfully and the clot was retrieved / removed resulting in a tici score of 3.It was reported that per the lead tech, ¿it was difficult anatomy and the physician had said to bag the 2 large bore catheters for a complaint.¿ the distal tips look damaged from can be discerned in the bags.The patient was reported to be fine post-procedure.There was no negative patient impact reported as a result of the reported issues.On 04-jan-2024, additional information was received.Per the information.¿there was no break or fracture of [the] tips but yes, collapsed and compressed.One rolled up like a ribbon.¿ the devices were returned for evaluation and analyses.Based on the product investigation completed on (b)(6) 2024.A fractured condition was noted in one of the two embovac catheters.Based on the completed product investigation, this event has been deemed usfda reportable under 21 cfr 803 with a classification of ¿malfunction.¿.

• Brand Name: 132CM LARGE BORE 71 CATHETER
• Common Device Name: CATHETER, ASPIRATION CATHETER
• 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: 18754945
• Report Number: 3008114965-2024-00256
• Device Sequence Number: 3838131
• Product Code: NRY
• UDI-Device Identifier: 10886704082378
• UDI-Public: 10886704082378
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K191237
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/21/2024

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: 12/31/2024
• Device Catalogue Number: IC71132UG
• Device Lot Number: 31117548
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/21/2024
• Initial Report FDA Received Date: 02/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/10/2023
• 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: 4MM X 41MM TREVO NXT¿ STENT RETRIEVER (STRYKER).; APRO¿* 70 ASPIRATION CATHETER (MEDTRONIC).
• Patient Age: 67 YR
• Patient Sex: Female