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

Model Number	MNC30015
Medical Device Problem Codes	Difficult to Remove (1528); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/05/2022
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 sample analysis results confirm that there was no indication of a product quality deficiency in the batch under investigation.Attempts were made to obtained 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.Neither the batch manufacturing record (bmr) review nor the control sample analysis including the complaint history review suggests that the reported failures could 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): k160961).
Event or Problem Description
As reported, 3.00 x 15 mm mozec¿ nc rx ptca balloon dilatation catheter was used for the procedure.It has been stated the transition profile was insufficient in the transition into the vessel and stent, the procedures were failure due to lack of sufficient flexibility and lubricity, the balloon compliance was limited and the risk of procedural myocardial infarction increased due to the delay experienced due to the problem in retraction of the balloon.

• 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: 15967847
• Report Number: 3009613036-2022-00006
• Device Sequence Number: 20251145
• Product Code: LOX
• UDI-Device Identifier: 18906029358384
• UDI-Public: 18906029358384
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: K160961
• 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): 12/13/2022

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: 03/23/2025
• Device Model Number: MNC30015
• Device Catalogue Number: MNC30015
• Device Lot Number: PMNCG16
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2022
• Initial Report FDA Received Date: 12/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/24/2022
• 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: 66 YR
• Patient Sex: Unknown