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

Model Number	MNC25028
Medical Device Problem Codes	Difficult to Remove (1528); Device Issue (2379); Mechanical Jam (2983); Positioning Problem (3009)
Health Effect - Clinical Code	No Information (3190)
Date of Event	09/18/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The distal shaft of the catheter was found kinked.Thus, the inner lumen of the catheter did not allow guidewire advancement during lab analysis.A review of same lot history record identified no manufacturing nonconformities.Additionally, a review of the complaint history identified, no other incident from same lot.Based on the information reviewed, there is no indication of product quality issue with respect to manufacturing, design and labelling.Please note: this is the first electronic report being filed, and it was delayed due to the sign up process with the esg webtrader system.
Event or Problem Description
Mozectm nc rx percutaneous transluminal coronary angioplasty (ptca) 2.50mm x 28mm was tracked over a non-cordis wire and inflated at twenty atmospheres (20atm).The balloon initially tacked well over the wire but after multiple inflations, when the user was pulling the balloon out, the wire got stuck into the balloon.The balloon and the wire were removed together and the balloon was rewired.The procedure was conducted for a chronic total occlusion (cto) of the left anterior descending (lad).No patient injury has been 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; muktanand marg, chala; vapi, gujarat 39619 1|; IN 396191|
• MDR Report Key: 7033679
• Report Number: 3009613036-2017-00001
• Device Sequence Number: 2037758
• Product Code: LOX
• UDI-Device Identifier: 18906029358254
• UDI-Public: 18906029358254
• Combination Product (Y/N): N
• 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: Health Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 11/15/2017

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: 12/08/2019
• Device Model Number: MNC25028
• Device Catalogue Number: MNC25028
• Device Lot Number: MNCE49
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/03/2017
• Initial Report FDA Received Date: 11/15/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other