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

Model Number	MNC25035
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Review of device history 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.Additionally, review of the complaint history identified no other similar incidents reported from this lot.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.Neither the dhr review nor the complaint history review suggests that the reported failures could be related to the design or manufacturing process.A supplement report will be issued, if additional information is received in the future.(b)(4).
Event or Problem Description
As reported, a 2.50 x 35 mm mozectm nc - rx ptca balloon dilatation catheter was used for the procedure.During inflation the balloon burst.There is no patient injury reported.

• 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, 39619 1; IN 396191
• MDR Report Key: 9392241
• Report Number: 3009613036-2019-00004
• Device Sequence Number: 11190362
• Product Code: LOX
• UDI-Device Identifier: 18906029359350
• UDI-Public: 18906029359350
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K160961
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/30/2019

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: 06/30/2020
• Device Model Number: MNC25035
• Device Catalogue Number: MNC25035
• Device Lot Number: MNCG99
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/08/2019
• Initial Report FDA Received Date: 11/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 76 YR