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

Model Number MOZ20012

Device Problems Sticking (1597); Physical Resistance (2578); Physical Property Issue (3008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/30/2018

Event Type  malfunction  

Manufacturer Narrative

The concomitant device mozectm - rx ptca balloon dilatation catheter was returned for analysis.The product was received with the guidewire stuck to the balloon catheter.A visual examination of balloon identified that the balloon had blood and saline traces in it and the balloon was stuck on the guidewire.A visual and tactile examination of the hypotube revealed multiple kinks on proximal shaft and at the rx port, and bend near the luer hub.Further, the catheter shaft was observed to be deformed.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.Balloon preparation, deployment and retraction test (simulated use) were performed on one (01) control sample from the same lot (lot # umoc34) of mozectm - rx ptca balloon dilatation catheter.No evidence of blocking of the catheter guidewire lumen during the flushing of the catheter guidewire lumen was noticed.The mozectm was prepared to access the simulated coronary vasculature and inflated to rated burst pressure without encountering any resistance or causing kink, bend, breakage or any other visual damage.Also the catheter was removed from the deployment site without any resistance or causing kink, bend, breakage or any other visual damage to the catheter or accessory devices.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 conform that there is no indication of a product related quality deficiency associated to this batch.Control sample test results of the same manufacturing lot again confirms that there was no indication of a product quality deficiency.Additionally, a review of the complaint history identified no other incidents from this lot.

Event Description

Physician was attempting to pre dilatate the left circumflex artery.The mozec 2.00x12 was loaded on a shinobi.014 wire and inserted into the lesion.After predilation, the mozec was hung on the wire and the wire / balloon were removed as a unit.The balloon is still loaded on that wire.To complete the procedure the physician rewired the vessel and inserted an abbott balloon.

• Brand Name: MOZECTM RX PTCA BALLOON DILATATION CATHETER
• Type of Device: 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
• Manufacturer (Section G): MERIL LIFE SCIENCES PVT. LTD.; bilakhia house, survey no. 135; muktanand marg; chala, vapi 39619 1; IN 396191
• Manufacturer Contact: narendra patel ; bilakhia house, survey no. 135; muktanand marg; chala, vapi 39619-1 ; IN 396191
• MDR Report Key: 7477760
• MDR Text Key: 107698976
• Report Number: 3009613036-2018-00011
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 18904224907581
• UDI-Public: 18904224907581
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131169
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Health Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 05/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/26/2020
• Device Model Number: MOZ20012
• Device Catalogue Number: MOZ20012
• Device Lot Number: UMOC34
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/04/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/27/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 49 YR
• Patient Weight: 79