MAUDE Adverse Event Report: MERIL LIFE SCIENCES PRIVATE LIMITED MOZECTM NC RX PTCA BALLOON DILATATION CATHETER; RAPID EXCHANGE PTCA BALLOON DILATATION CATHETER

Model Number	MNC45013
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/18/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Review of batch manufacturing record (bmr) including raw material inspection, in process & finished product inspection, does not reveal any discrepancy relevant to the batch under investigation, which confirms that there is no indication of a product related quality deficiency associated with this batch.Control sample analysis results confirm that there was no indication of a product quality deficiency in the batch under investigation.Moreover, review of the complaint history identified no other incidents reported from this batch.It is further to be noted that the reported event, i.E."deflation issue" is known risk and is adequately mentioned in the risk management report.Additionally, the instructions relevant to the reported event are adequately mentioned in the ifu.The device was not returned for analysis.Based on the available information and without the concomitant device, the reported customer complaint could not be confirmed and no determination of possible contributing factors could be made and it is not possible to draw a clinical conclusion between the device and the reported event.Considering the above and as clinical situations cannot be duplicated in our analysis lab, the exact root cause of the difficulty could not be determined.Review of the batch manufacturing record (bmr), complaint history and control sample analysis results suggest that the reported failures could not be related to the design or the manufacturing process.Note: this complaint is recieved from outside the usa.No units of this batch has been distributed in the usa.However, it is being reported to the usfda as this product is cleared in the usa (510(k): k181023).
Event or Problem Description
As reported, 4.50x13 mm mozec¿ nc rx ptca balloon dilatation catheter was used for the procedure.The target lesion was mid rca with severe tortuosity, 80% calcification and 80% stenosis.The balloon was placed mid to proximal in the rca.The balloon did not deflate during the procedure.(the ballon took 1.5 - 2 minutes to deflate).The device was used in 62 years old male patient.The target lesion was mid rca with severe tortuosity, 80% calcification and 80% stenosis.The device was stored and handled per the ifu.There were no anomalies noted to the device when it was taken out of the packaging.There was no difficulty in removing the product from the hoop.There was no difficulty in removing the stylet.The device was prepped per the ifu.The device was prepped normally.There was no anomaly noted during or after the device was prepped.The product was inspected prior to use and appeared to be normal.There was no unusual force used during the loading on guidewire.There was no resistance/friction experienced while inserting the device through the rotating hemostatic valve.There was no resistance/friction experienced while inserting the device through the guide catheter.There was no resistance and/ or abnormal device interaction notice during the device advancement.The device was never in an acute bend condition.There was no excessive force used while advancing the device to cross the target lesion/stent.There was no inflation difficulty experienced during the procedure.There was no patient injury reported.Current status of the patient is stable.There was no prolongation of hospitalization period due to this event.
Event or Problem Description
As reported, 4.50x13 mm mozec¿ nc rx ptca balloon dilatation catheter was used for the procedure.The target lesion was mid rca with severe tortuosity, 80% calcification and 80% stenosis.The balloon was placed mid to proximal in the rca.The balloon did not deflate during the procedure.(the ballon took 1.5 - 2 minutes to deflate).The device was used in 62 years old male patient.The target lesion was mid rca with severe tortuosity, 80% calcification and 80% stenosis.The device was stored and handled per the ifu.There were no anomalies noted to the device when it was taken out of the packaging.There was no difficulty in removing the product from the hoop.There was no difficulty in removing the stylet.The device was prepped per the ifu.The device was prepped normally.There was no anomaly noted during or after the device was prepped.The product was inspected prior to use and appeared to be normal.There was no unusual force used during the loading on guidewire.There was no resistance/friction experienced while inserting the device through the rotating hemostatic valve.There was no resistance/friction experienced while inserting the device through the guide catheter.There was no resistance and/ or abnormal device interaction notice during the device advancement.The device was never in an acute bend condition.There was no excessive force used while advancing the device to cross the target lesion/stent.There was no inflation difficulty experienced during the procedure.There was no patient injury reported.Current status of the patient is stable.There was no prolongation of hospitalization period due to this event.
Additional Manufacturer Narrative
This report is being submitted due to correction of the brand name (section d1).Review of batch manufacturing record (bmr) including raw material inspection, in process & finished product inspection, does not reveal any discrepancy relevant to the batch under investigation, which confirms that there is no indication of a product related quality deficiency associated with this batch.Control sample analysis results confirm that there was no indication of a product quality deficiency in the batch under investigation.Moreover, review of the complaint history identified no other incidents reported from this batch.It is further to be noted that the reported event, i.E."deflation issue" is known risk and is adequately mentioned in the risk management report.Additionally, the instructions relevant to the reported event are adequately mentioned in the ifu.The device was not returned for analysis.Based on the available information and without the concomitant device, the reported customer complaint could not be confirmed and no determination of possible contributing factors could be made and it is not possible to draw a clinical conclusion between the device and the reported event.Considering the above and as clinical situations cannot be duplicated in our analysis lab, the exact root cause of the difficulty could not be determined.Review of the batch manufacturing record (bmr), complaint history and control sample analysis results suggest that the reported failures could not be related to the design or the manufacturing process.Note-1: this complaint is received from outside the usa.No units of this batch has been distributed in the usa.However, it is being reported to the usfda as this product is cleared in the usa (510(k): k181023).Note-2: the manufacturing date is not included on the product label as a part of pi for the usa market.Therefore, it is not included in the gudid.The "device manufacture date" captured in the form 3500a is taken from the batch manufacturing record of batch # mncu94.

• Brand Name: MOZECTM NC RX PTCA BALLOON DILATATION CATHETER
• Common Device Name: RAPID EXCHANGE PTCA BALLOON DILATATION CATHETER
• Manufacturer (Section D): MERIL LIFE SCIENCES PRIVATE LIMITED; survey number 135/139; bilakhia house, muktanand marg; chala, vapi, gujarat 39619 1; IN 396191
• Manufacturer (Section G): MERIL LIFE SCIENCES PRIVATE LIMITED; survey number 135/139; bilakhia house, muktanand marg; chala, vapi, gujarat 39619 1; IN 396191
• Manufacturer Contact: narendra patel ; survey number 135/139; bilakhia house, muktanand marg; chala, vapi, gujarat 39619-1 ; IN 396191
• MDR Report Key: 17981741
• Report Number: 3009613036-2023-00002
• Device Sequence Number: 3430198
• Product Code: LOX
• UDI-Device Identifier: 18906029359527
• UDI-Public: 18906029359527
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: K181023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/02/2025

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: 05/27/2025
• Device Model Number: MNC45013
• Device Catalogue Number: MNC45013
• Device Lot Number: MNCU94
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/29/2023
• Supplement Date Received by Manufacturer: 09/29/2023
• Initial Report FDA Received Date: 10/21/2023
• Supplement Report FDA Received Date: 01/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/28/2022
• 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
• Patient Age: 62 YR
• Patient Sex: Male