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

Model Number MOZ25009

Device Problems Mechanical Problem (1384); Failure to Advance (2524); Patient-Device Incompatibility (2682); Positioning Problem (3009)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/27/2017

Event Type  malfunction  

Manufacturer Narrative

During processing of this complaint, attempts were made to obtain complete event, patient and device information.There was no leak noted during preparation prior to use, which suggests a product quality issue did not contribute to the reported difficulties.Patient anatomy especially lesion morphology such as highly calcified & narrow lesion, vessel tortuosity, thrombus burden can likely contribute to the crossing/withdrawal difficulties.Patient had very tortuous vessels.Aforesaid tortuous vessel might have offered high resistance while maneuvering the catheter system which led to the reported problem.Returned product analysis reveals a kink on the proximal shaft near the luer hub.Such type of kink is associated with excessive force being applied on balloon catheter during use.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.It might be possible that highly tortuous vessel offered high resistance during lesion crossing that led to the reported case.However, as clinical situation cannot be duplicated in our analysis lab, the exact root cause of the difficulty could not be determined.

Event Description

Balloon was unable to cross.Patient had very tortuous vessels.Dr.Park started radially and had to switch to groin due to tortuous vessels.He tried to cross with a mozec 2.5x09 balloon.He ended up using a competitor over the wire balloon of same size just to get extra pushability to get across lesion (he never inflated that balloon), then he used a larger sizen mozec3.0x09 balloon and was able to get across lesion and pre-dilate prior to stenting.There was no reported clinically significant delay in the procedure.There was no reported patient injury.

• 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; 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: 7064464
• MDR Text Key: 93769672
• Report Number: 3009613036-2017-00004
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 18904224907697
• UDI-Public: 18904224907697
• 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: Physician
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 11/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/23/2020
• Device Model Number: MOZ25009
• Device Catalogue Number: MOZ25009
• Device Lot Number: UMOA87
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/01/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/24/2017
• 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 Outcome(s): Required Intervention
• Patient Age: 79 YR