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

Model Number	MOZ20015
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/18/2019
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.Additionally, a review of the complaint history identified no other incidents reported from this lot.Moreover, the instructions for use (ifu) of mozec cautions users to examine the ptca catheter prior to the angioplasty to verify functionality and to ensure that its size and shape are suitable for the specific procedure for which it is to be used.The ifu instructs any product with damage to not be used.If resistance is encountered at any time during the insertion procedure, do not force passage.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.
Event or Problem Description
An angiography was performed on coronary arteries which determined that the lad was sub totally occluded.A pci was performed on lad of a female aged (b)(6) years.It took 20-30 minutes to successfully wire the lad with an abbott powerturn flex 0.014", 190cm interventional coronary wire.Upon successful wiring of the lad, a 2.00 x 15 mm mozec was placed onto the wire and became stuck (unable to advance or retract) outside of the guiding catheter.The wire was lubricated with saline at all times outside of the guiding catheter.Upon attempting to retract the mozec balloon off the wire, the balloon and delivery catheter hypotube became detached.At this time the hypotube was removed while the actual balloon was stuck on the wire.The wire was then cut with an attempt to remove the stuck balloon on the wire and advance another balloon on the same wire which was unsuccessful.The wire was ultimately removed and the vessel was rewired with a different abbott powerturn flex 0.014", 190 cm interventional coronary wire and the procedure was completed using boston scientific 2.0 x 20 mm rx emerge ptca balloon.No patient injury reported.

• Brand Name: MOZECTM 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
• MDR Report Key: 8406349
• Report Number: 3009613036-2019-00002
• Device Sequence Number: 389606
• Product Code: LOX
• UDI-Device Identifier: 18904224907598
• UDI-Public: 18904224907598
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/09/2019

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: 04/27/2021
• Device Model Number: MOZ20015
• Device Catalogue Number: MOZ20015
• Device Lot Number: UMOD89
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2019
• Initial Report FDA Received Date: 03/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 71 YR