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

Model Number	MNC27515
Medical Device Problem Codes	Failure to Advance (2524); Failure to Deflate (4060)
Health Effect - Clinical Code	Insufficient Information (4580)
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 to this batch.Review of the complaint history identified no other incidents reported from this batch.Control samples analysis results confirm that there was no indication of a product quality deficiency in the batch under investigation.Attempts were made to obtain concomitant device and additional information.However, all requested information and concomitant device was not received.Without the return of the device for analysis, the reported customer complaint could not be confirmed and no determination of possible contributing factors could be made.Based on the available information and without the concomitant device, 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 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).
Event or Problem Description
As reported, 2.75 x 15 mm, mozec¿ nc rx ptca balloon dilatation catheter was used for the procedure.It has been stated that the flexibility and lesion passage were not sufficient, it was challenging to pass through the stent, balloon compliance was low, the deflation was delayed during the balloon deflation and that this was not suitable for use due to the increase of periprocedural mi risk.

• Brand Name: MOZEC¿ 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: 16829434
• Report Number: 3009613036-2023-00001
• Device Sequence Number: 12543840
• Product Code: LOX
• UDI-Device Identifier: 18906029358308
• UDI-Public: 18906029358308
• 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
• Report Date (Section B): 04/28/2023

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: 08/02/2025
• Device Model Number: MNC27515
• Device Catalogue Number: MNC27515
• Device Lot Number: MNCV26
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2023
• Initial Report FDA Received Date: 04/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/03/2022
• 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 Sex: Unknown