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

Model Number	MNC35008
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Review of batch manufacturing 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 analysis 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 batch.Based on the available information and without the concomitant device, it is not possible to draw a clinical conclusion between the device and the reported event.Neither the batch manufacturing record review nor the control sample analysis results including the complaint history review suggests that the reported failures could be related to the design or manufacturing process.
Event or Problem Description
As reported, the 3.50 x 08 mozec nc balloon became lodged on the pci wire and was unable to be advanced or removed.The balloon and wire had to be removed from the patient.Once out of the patient, the balloon was still lodged on the wire and could not be removed.The pci wire used was a 0.014" balanced middle weight (bmw) wire.A new bmw wire was used along with a 3.5 x 8 nc quantum balloon (boston sci) to complete the case.There was no adverse event or harm to the patient as a result of this incident.The sheath used was a 6f rain sheath in the right radial artery.The guiding catheter used was a 6f xb3.5 vista brite tip guiding catheter.The balloon catheter was prepped in the usual fashion per the ifu.There was no visible damage to the catheter prior to loading on the wire.The balloon was never inflated, as it became lodged on the wire prior to exiting the guiding catheter.The balloon catheter was stored on a supply cart in the procedure area with controlled temperature and humidity.
Additional Manufacturer Narrative
Review of batch manufacturing 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 analysis 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 batch.Return product analysis indicates that, the mozec¿ nc - rx ptca balloon dilatation catheter might not have contributed to the reported incident.The most probable cause of the incident is guide wire deformation.Based on the complaint investigation and available information there is no evidence to suggest that the event was design or manufacturing related.Neither the batch manufacturing record review nor the control sample analysis results including analysis of return device and complaint history review suggests that the reported failures could be related to the design or manufacturing process.
Event or Problem Description
As reported, the 3.50 x 08 mozec nc balloon became lodged on the pci wire and was unable to be advanced or removed.The balloon and wire had to be removed from the patient.Once out of the patient, the balloon was still lodged on the wire and could not be removed.The pci wire used was a 0.014" balanced middle weight (bmw) wire.A new bmw wire was used along with a 3.5 x 8 nc quantum balloon (boston sci) to complete the case.There was no adverse event or harm to the patient as a result of this incident.The sheath used was a 6f rain sheath in the right radial artery.The guiding catheter used was a 6f xb3.5 vista brite tip guiding catheter.The balloon catheter was prepped in the usual fashion per the ifu.There was no visible damage to the catheter prior to loading on the wire.The balloon was never inflated, as it became lodged on the wire prior to exiting the guiding catheter.The balloon catheter was stored on a supply cart in the procedure area with controlled temperature and humidity.The device was used for the 87 years old person weighing 68 kg.There was no difficulty in removing the product from the hoop.There was no difficulty in removing the protective balloon cover.There was no unusual force used during the loading on guide wire.There was no resistance/friction experienced while inserting the device through the rotating haemostatic valve.There was no resistance/friction experienced while inserting the device through the guide catheter prior to the point of becoming lodged on the wire within the guide catheter.The catheter was never in an acute bend condition.There was no damage noted after the device was removed from the patient.The guide wire was inspected prior to use and it appeared to be normal.The guide wire was not used in multiple procedure before this event.There was no damage or anomaly noted on the part of the wire able to be visualized (the balloon was lodged on the wire).There was no significant delay in the procedural time other than re-wiring the vessel.
Additional Manufacturer Narrative
Review of batch manufacturing 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 analysis 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 batch.Based on the available information and without the concomitant device, it is not possible to draw a clinical conclusion between the device and the reported event.Neither the batch manufacturing record review nor the control sample analysis results including the complaint history review suggests that the reported failures could be related to the design or manufacturing process.
Event or Problem Description
As reported, the 3.50 x 08 mozec nc balloon became lodged on the pci wire and was unable to be advanced or removed.The balloon and wire had to be removed from the patient.Once out of the patient, the balloon was still lodged on the wire and could not be removed.The pci wire used was a 0.014" balanced middle weight (bmw) wire.A new bmw wire was used along with a 3.5 x 8 nc quantum balloon (boston sci) to complete the case.There was no adverse event or harm to the patient as a result of this incident.The sheath used was a 6f rain sheath in the right radial artery.The guiding catheter used was a 6f xb3.5 vista brite tip guiding catheter.The balloon catheter was prepped in the usual fashion per the ifu.There was no visible damage to the catheter prior to loading on the wire.The balloon was never inflated, as it became lodged on the wire prior to exiting the guiding catheter.The balloon catheter was stored on a supply cart in the procedure area with controlled temperature and humidity.The device was used for the 87 years old person weighing 68 kg.There was no difficulty in removing the product from the hoop.There was no difficulty in removing the protective balloon cover.There was no unusual force used during the loading on guide wire.There was no resistance/friction experienced while inserting the device through the rotating haemostatic valve.There was no resistance/friction experienced while inserting the device through the guide catheter prior to the point of becoming lodged on the wire within the guide catheter.The catheter was never in an acute bend condition.There was no damage noted after the device was removed from the patient.The guide wire was inspected prior to use and it appeared to be normal.The guide wire was not used in multiple procedure before this event.There was no damage or anomaly noted on the part of the wire able to be visualized (the balloon was lodged on the wire).There was no significant delay in the procedural time other than re-wiring the vessel.

• Brand Name: MOZEC NC - RX PTCA BALLOON DILATATION CATHETER
• Common Device Name: RAPID EXCHANGE PTCA BALLOON DILATATION CATHETER
• Manufacturer (Section D): MERIL LIFE SCIENCES PRIVATE LIMITED; survey number 135/139; bilakhia house, muktanand marg; chala, vapi, gujarat 39619 1; IN 396191
• MDR Report Key: 11640076
• Report Number: 3009613036-2021-00001
• Device Sequence Number: 17003296
• Product Code: LOX
• UDI-Device Identifier: 18906029358438
• UDI-Public: 18906029358438
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K160961
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/12/2021

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: 04/23/2021
• Device Model Number: MNC35008
• Device Catalogue Number: MNC35008
• Device Lot Number: MNCL10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/16/2021
• Supplement Date Received by Manufacturer: 03/16/2021; 03/16/2021
• Initial Report FDA Received Date: 04/09/2021
• Supplement Report FDA Received Date: 05/18/2021; 06/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 87 YR
• Patient Weight: 68