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

Model Number	MOZ20012
Medical Device Problem Codes	Material Deformation (2976); Material Twisted/Bent (2981); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/19/2018
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.Based on the available information there is no evidence to suggest that the event was design or manufacturing related.Neither the dhr review nor complaint history review suggest that the reported failures could be related to the design or the manufacturing process.
Event or Problem Description
The target lesion was severely calcified and moderately tortuous.The device was prepped normal as per the ifu.The product was inspected prior to use and appeared to be normal.There were no kinks or other damages noted prior to the insertion of the product into the patient.The physician experienced resistance/friction while crossing the target lesion and the device failed to cross the lesion.No inflation/deflation were performed.The catheter was then retracted from the patient, while removing no excess force was used.Upon removal from the patient, the physician noticed that the rx port was extremely twisted.
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.Moreover, review of the complaint history identified no other incidents reported from this lot.The instructions for use (ifu) of mozec cautions users to examine the ptca catheter prior to the angioplasty to verify functionality and to ensure that its size and shape are suitable for the specific procedure for which it is to be used.The ifu instructs any product with damage to not be used.Per reported event description, the product was inspected prior to use and appeared to be normal and there were no kinks or other damages noted prior to the insertion of the product into the patient.Based on the event description and the condition of the returned catheter, and the most probable root cause is operational context.Based on the available information there is no evidence to suggest that the event was design or manufacturing related.Neither the dhr review nor the returned product analysis including complaint history review suggests that the reported failures could be related to the design or the manufacturing process.- attachment: [complaint evaluation report_moz-pc18-032.Pdf].
Event or Problem Description
The target lesion was severely calcified and moderately tortuous.The device was prepped normal as per the ifu.The product was inspected prior to use and appeared to be normal.There were no kinks or other damages noted prior to the insertion of the product into the patient.The physician experienced resistance/friction while crossing the target lesion and the device failed to cross the lesion.No inflation/deflation was performed.The catheter was then retracted from the patient while removing no excess force was used.The physician noticed that the rx port was extremely twisted.The patient was male.There was no damage noted to the packaging of the device and the device was removed from the package without encountering any difficulty.There was no difficulty in removing the product from the hoop and protective balloon cover.The product was inspected prior to use and appeared to be normal.There were no kinks or other damages noted prior to the insertion of the product into the patient.The device was not advanced with the indeflator connected to the hub.There was no resistance experienced while inserting the balloon through the rotating hemostatic valve.There was no torque applied while maneuvering the device to the target lesion.The catheter was never in an acute bend condition.Resistance was experienced while crossing the target lesion and the device did not cross the target lesion.No inflation/deflation was performed.The balloon catheter was never wrapped around the guide wire and no excessive force used during withdrawal.

• Brand Name: MOZECTM RX PTCA BALLOON DILATATION CATHETER
• Common Device Name: RAPID EXCHANGE PTCA BALLOON DILATATION CATHETER
• Manufacturer (Section D): MERIL LIFE SCIENCES PVT. LTD.; survey number 135/139; bilakhia house, muktanand marg; chala, vapi, gujarat 39619 1; IN 396191
• MDR Report Key: 8254271
• Report Number: 3009613036-2018-00029
• Device Sequence Number: 16626601
• Product Code: LOX
• UDI-Device Identifier: 18904224907581
• UDI-Public: 18904224907581
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K131169
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/27/2021
• Device Model Number: MOZ20012
• Device Catalogue Number: MOZ20012
• Device Lot Number: UMOD88
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2019
• Initial Date Received by Manufacturer: 12/21/2018
• Supplement Date Received by Manufacturer: 12/21/2018
• Initial Report FDA Received Date: 01/16/2019
• Supplement Report FDA Received Date: 02/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1