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

Model Number MOZ25014

Device Problem Physical Resistance/Sticking (4012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/06/2019

Event Type  malfunction  

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.Control sample test results confirm that there was no indication of a product quality deficiency in the batch under investigation.Additionally, review of the complaint history identified no other similar incidents reported from this lot.Based on the available information and investigation outcome, it was presumed that a damage guidewire might have resulted to the reported incident.It is likely that the guidewire may have encountered resistance while manipulation & subsequent damage during advancement and/or withdrawal attempts.Therefore, the reported balloon catheter stuck over the guidewire appears to be related to circumstances of the procedure.The availability of the guide wire used is unknown.Without the concomitant device and the guidewire used, it is not possible to draw a clinical conclusion between the device and the reported event.Considering above and as clinical situations cannot be duplicated in our analysis lab, a conclusive cause for the reported incident, and the relationship to the product, if any, cannot be determined.Neither the dhr review nor the control sample analysis including complaint history review suggests that the reported failures could be related to the design or the manufacturing process.(b)(4).

Event Description

As reported, the balloon stuck on the wire coming out of the patient.No patient injury was reported.No additional information was provided.Multiple attempts were made to obtain complete event, patient and device information; however, no information has been received till date.

• Brand Name: MOZECTM RX PTCA BALLOON DILATATION CATHETER
• Type of Device: RAPID EXCHANGE PTCA BALLOON DILATATION CATHETER
• Manufacturer (Section D): MERIL LIFE SCIENCES PRIVATE LIMITED; survey number 135/139; bilakhia house, muktanand marg; chala, vapi, 39619 1; IN 396191
• Manufacturer (Section G): MERIL LIFE SCIENCES PRIVATE LIMITED; survey number 135/139; bilakhia house, muktanand marg; chala, vapi, 39619 1; IN 396191
• Manufacturer Contact: narendra patel ; survey number 135/139; bilakhia house, muktanand marg; chala, vapi, gujarat 39619-1 ; IN 396191
• MDR Report Key: 8954889
• MDR Text Key: 202952516
• Report Number: 3009613036-2019-00003
• Device Sequence Number: 1
• Product Code: LOX
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/03/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2021
• Device Model Number: MOZ25014
• Device Catalogue Number: MOZ25014
• Device Lot Number: UMOD92
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/07/2019
• Initial Date FDA Received: 09/03/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/29/2018
• 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: 63 YR