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

Model Number IC71132UG

Device Problem Crack (1135)

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

Event Date 11/10/2020

Event Type  malfunction  

Manufacturer Narrative

Product complaint #: (b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.The product lot number is not available.(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 a healthcare professional, a 132cm large bore 71 catheter (ic71132ug, unknown lot) had a crack just distal to the strain relief after aspiration and while flushing the catheter on the back table.The physician reported that it looked as the visual damage was there prior to insertion and aspiration.They are not sure if it was from manufacturing, or from a team member taking it out of the hoop.Additional information received indicated that it is unknown how the device was handled and prepped.The device was used although the visual damage was noticed by the physician, and not the person prepping the device.There was no delay in the case.There was no patient injury reported.The procedure was successfully completed by using a competitor¿s device.It was assumed the device was not handled properly prior to use by staff, and another education on handling was performed by senior vanderbilt staff.The device was discarded, therefore, no further investigation can be performed.The manufacturing record evaluation (mre) cannot be performed due to the lot number was not provided.With the information available and without the product available for analysis, the reported customer complaint of ¿catheter (body/shaft)-cracked¿ could not be confirmed.The exact cause of the event could not be determined, however, there it was reported that the device was not handled properly prior to use by staff.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.

Event Description

As reported by a healthcare professional, a 132cm large bore 71 catheter (ic71132ug, unknown lot) had a crack just distal to the strain relief after aspiration, and while flushing the catheter on the back table.The physician reported that it looked as the visual damage was there prior to insertion and aspiration.They are not sure if it was from manufacturing, or from a team member taking it out of the hoop.Additional information received indicated that it is unknown how the device was handled, and prepped.The device was used although the visual damage was noticed by the physician and not the person prepping the device.There was no delay in the case.There was no patient injury reported.The procedure was successfully completed by using a competitor¿s device.It was assumed the device was not handled properly prior to use by staff, and another education on handling was performed by senior vanderbilt staff.

• Brand Name: 132CM 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 drive; irvine, CA 92618 ; 9497898687
• MDR Report Key: 10928217
• MDR Text Key: 219003334
• Report Number: 3008114965-2020-00542
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 10886704082378
• UDI-Public: 10886704082378
• 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
• Report Date: 11/12/2020

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
• Device Operator: Health Professional
• Device Model Number: IC71132UG
• Device Catalogue Number: IC71132UG
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/10/2020
• Initial Date FDA Received: 12/01/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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