MAUDE Adverse Event Report: MERIL LIFE SCIENCES PVT. LTD. MOZECTM RX PTCA BALLOON DILATATION CATHETER; RAPID EXCHANGE PTCA BALLOON DILATATION CATHETER

Model Number	MOZ30014
Medical Device Problem Codes	Material Rupture (1546); Physical Property Issue (3008)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/29/2018
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 batch under investigation which confirms that there is no indication of a product related quality deficiency associated to this batch.Control sample test results of the same manufacturing batch again confirm that there was no indication of a product quality deficiency.There was no anomaly noted during or after the device was prepared.The lesion was very calcified (prox.Lad) and hence tracking difficulty noted while maneuvering through the lesion.Additionally, a review of the complaint history identified no other incidents from this batch.Neither the dhr review nor the control sample analysis suggests that the event could be related to the batch under investigation, design or manufacturing process.(b)(4).
Event or Problem Description
During a percutaneous transluminal coronary angioplasty (ptca) procedure, the mozec balloon ruptured.

• Brand Name: MOZECTM RX PTCA BALLOON DILATATION CATHETER
• Common Device Name: RAPID EXCHANGE PTCA BALLOON DILATATION CATHETER
• Manufacturer (Section D): MERIL LIFE SCIENCES PVT. LTD.; bilakhia house, survey no. 135; muktanand marg; chala, vapi 39619 1; IN 396191
• MDR Report Key: 7557005
• Report Number: 3009613036-2018-00016
• Device Sequence Number: 1818157
• Product Code: LOX
• UDI-Device Identifier: 18904224907888
• UDI-Public: 18904224907888
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K131169
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 05/31/2018

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: 10/11/2020
• Device Model Number: MOZ30014
• Device Catalogue Number: MOZ30014
• Device Lot Number: UMOC45
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/02/2018
• Initial Report FDA Received Date: 05/31/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1