MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL 125CM LARGE BORE 71 CATHETER; CATHETER, ASPIRATION CATHETER

Model Number IC71125UG

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/22/2021

Event Type  malfunction  

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.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

As reported by the field, during the use of a 125cm large bore 71 catheter (ic71125ug, 30521668) for a stroke intervention, the physician noted that during the prepping of the catheter, there was leakage air/fluids near the hub of the catheter.When asked if it came out of the packaging with a kink, he said that he believed there was a chance that the catheter may have been mishandled on the back table by a technician.The procedure was completed by using a different product.It is possible that excessive force was used on the device during the handling/prepping of the device.There was no prolongation during the procedure due to the event.

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 the use of a 125cm large bore 71 cathetheter (ic71125ug, 30521668) for a stroke intervention, the physician noted that during the prepping of the catheter, there was leakage air/fluids near the hub of the catheter.When asked if it came out of the packaging with a kink, he said that he believed there was a chance that the catheter may have been mishandled on the back table by a technician.The procedure was completed by using a different product.It is possible that excessive force was used on the device during the handling/prepping of the device.There was no prolongation during the procedure due to the event.The product was returned to cerenovus for evaluation.Visual inspection and dimensional testing were conducted on the returned device.The visual analysis of the returned 125cm large bore 71 catheter revealed that the device has a kinked/twisted condition near to the id band.Also, it was noted compressed at 26 inches to 27 inches and 32 inches to 33 inches from the proximal end.No other damages or anomalies were observed during the visual inspection.The kinked/twisted condition could be related with a device interaction and device manipulation since according to the information received there was a chance that the catheter may have been mishandled on the back table by a technician, this could have generated the kinked/twisted condition and subsequently the cracked condition of the device.The 125cm large bore 71 catheter was flushed to verify if any leakage was present on the device, a leakage was noted at kinked/twisted noted on the visual analysis, the id band was removed and a hole was found at this section, the hole observed at the kinked/twisted section is related to the leakage.A manufacturing record evaluation (mre) was performed for the finished device 30521668 number, and no non-conformances related to the malfunction were identified.Based on the findings during the analysis, the customer complaint regarding ¿catheter (body/shaft) ¿ leakage¿ was confirmed.During the dimensional testing it was noted that the id and od of the 132cm embovac 71 asp.Catheter is within specification.A manufacturing record evaluation was performed, and no non-conformances related to the reported complaint condition were identified.It should be noted that product failure is multifactorial.The instructions for use contain the following precautions: exercise care in handling the large bore catheter to reduce the chance of accidental damage.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: 125CM LARGE BORE 71 CATHETER
• Type of Device: CATHETER, ASPIRATION CATHETER
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel CH-24 00; SZ CH-2400
• Manufacturer (Section G): CODMAN AND SHURTLEFF, INC (MIRAMAR); 3260 executive way; miramar FL 33025
• Manufacturer Contact: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 12750584
• MDR Text Key: 284812620
• Report Number: 3008114965-2021-00552
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 10886704082361
• UDI-Public: 10886704082361
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K191237
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2022
• Device Model Number: IC71125UG
• Device Catalogue Number: IC71125UG
• Device Lot Number: 30521668
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/11/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/08/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1