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

Model Number	MNC20015
Medical Device Problem Codes	Entrapment of Device (1212); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/20/2018
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 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 and the control sample test results also confirm that there was no indication of a product quality deficiency.Based on the available information and without 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 including control sample analysis results suggests that the reported failures could be related to design or manufacturing process.[(b)(4)].
Event or Problem Description
The surgeon used a 2.0x15 mozec nc to pre-dilate a lesion during a coronary intervention.The balloon was inflated and deflated four ( 4) times.When trying to remove the balloon, it got stuck on the sion blue wire.The sion blue wire was removed with mozec balloon still on it.The vessel was re-wired to complete the procedure with a non-meril device.No patient injuries were reported.
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 and the control sample test results also confirm that there was no indication of a product quality deficiency.Based on the available information and observations of the returned device, it is not possible to determine the probable root cause for this event.However, since neither the dhr review nor the returned product analysis including control sample analysis results suggest that the reported failures could be related to design or manufacturing process.Visual observations of the returned product included relaxed balloon wings indicating the balloon was subjected to positive pressure; visible contrast medium in the lumen and the balloon body; blood traces at the rx port and in the inner lumen along with a damaged (torn) rx port; multiple kinks along the catheter length on the proximal shaft and a bend near the luer hub.Multiple attempts were made to maneuver a recommended test guidewire (0.014") through the catheter lumen, but the presence of solidified contrast media along with blood traces and the apparent damages on the catheter shaft made this unfeasible.- attachment: [complaint evaluation report for mnc-pc18-020.Pdf, complaint evaluation report_moz-pc18-020_returned product analysis.Pdf].
Event or Problem Description
The surgeon used a 2.0x15 mozec nc to pre-dilate a lesion during a coronary intervention.The balloon was inflated and deflated four ( 4) times.When trying to remove the balloon, it got stuck on the sion blue wire.The sion blue wire was removed with mozec balloon still on it.The vessel was re-wired to complete the procedure with a non-meril device.No patient injuries were 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 PVT. LTD.; bilakhia house, survey no. 135; muktanand marg; chala, vapi 39619 1; IN 396191
• MDR Report Key: 7882779
• Report Number: 3009613036-2018-00020
• Device Sequence Number: 11444575
• Product Code: LOX
• UDI-Device Identifier: 18906029358063
• UDI-Public: 18906029358063
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 11/13/2018

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: 06/22/2020
• Device Model Number: MNC20015
• Device Catalogue Number: MNC20015
• Device Lot Number: MNCG88
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2018
• Initial Date Received by Manufacturer: 08/23/2018
• Supplement Date Received by Manufacturer: 08/23/2018
• Initial Report FDA Received Date: 09/17/2018
• Supplement Report FDA Received Date: 11/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SION BLUE WIRE; SION BLUE WIRE