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

Device Problem Retraction Problem (1536)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

Review of batch manufacturing records 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.Control sample test results confirm that there was no indication of a product quality deficiency in the batch under investigation.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.Review of the complaint history identified no other incidents reported from this lot.Considering all above and as the clinical situations cannot be duplicated in our analysis lab, a conclusive cause for the reported incident, and the relationship to the product, if any, cannot be determined.Neither the dhr review nor the control sample analysis including 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 from this batch has been distributed in the usa.However, it is being reported to the fda as this product is cleared in the usa.(b)(4).

Event Description

As reported, 3.00 x 15mm mozec(tm) nc rx ptca balloon dilatation catheter, batch #: mnco52 was used in a pci.While withdrawing, it was very difficult to retrieve without taking the guide wire.This increase the radiation time.

• Brand Name: MOZEC¿ NC - RX PTCA BALLOON DILATATION CATHETER
• Type of Device: 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: 9834371
• MDR Text Key: 203124731
• Report Number: 3009613036-2020-00002
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 18906029358384
• UDI-Public: 18906029358384
• Combination Product (y/n): N
• Reporter Country Code: CE
• PMA/PMN Number: K160961
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2021
• Device Model Number: MNC30015
• Device Catalogue Number: MNC30015
• Device Lot Number: MNCO52
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/17/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/18/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1