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

Model Number	MOZ20012
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/31/2018
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 attributed to the batch under investigation.This confirms that there is no indication of a product related quality deficiency associated to this batch.Additionally, a review of the complaint history identified no other incidents reported from this lot.Based on the available information there is no evidence to suggest that the event was design or manufacturing related.Neither the dhr review nor complaint history review suggest that the reported failures could be related to the design or the manufacturing process.(b)(4).
Event or Problem Description
The mozec balloon was opened and passed off to the scrub tech and was prepped and placed on the wire.Once the balloon was placed into the blockage and inflated it wouldn't hold pressure.The balloon was removed and the scrub tech noticed there was a hole in the shaft and it was leaking.As reported, after the 2.00 x 12 mozec balloon was placed into the blockage and inflated, the balloon was not able to hold the pressure.Upon removal of the balloon, a hole was noted in the shaft and from where there was a leakage.Patient was male, weighing 200 pounds.The target lesion was ostial marginal with 90% stenosis and the vessel diameter was 2.5 mm.The lesion was moderately calcified and little tortuous.The device was not used for chronic total occlusion.The device was stored and handled as per the ifu.There was no damage noted to the packaging of the device.There was no difficulty in removing the product from the packaging.There was neither any difficulty in removing the product from the hoop, nor in removing the protective cover.The device was prepped as per the ifu during which no leakage was observed.The product was inspected prior to use and appeared to be normal.There were no kinks or other damages noted prior to the insertion of the product into the patient.There was no resistance/friction while inserting the balloon through the rotating hemostatic valve.There was no resistance/friction while crossing the target lesion.The balloon did not inflate normally.The maximum inflation was 7 atm, after which the pressure dropped.The product was removed intact from the patient and the procedure was completed with another balloon.No patient injury was reported.

• 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: 8120620
• Report Number: 3009613036-2018-00022
• Device Sequence Number: 13867240
• Product Code: LOX
• UDI-Device Identifier: 18904224907581
• UDI-Public: 18904224907581
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 11/30/2018

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: 02/15/2021
• Device Model Number: MOZ20012
• Device Catalogue Number: MOZ20012
• Device Lot Number: UMOD10
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/01/2018
• Initial Report FDA Received Date: 11/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 91