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

Model Number	MOZ25009
Medical Device Problem Codes	Mechanical Problem (1384); Failure to Advance (2524); Patient-Device Incompatibility (2682); Positioning Problem (3009)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/27/2017
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: RAPID EXCHANGE PTCA BALLOON DILATATION CATHETER
• Manufacturer (Section D): MERIL LIFE SCIENCES PVT. LTD; bilakhia house; muktanand marg; chala, vapi 39619 1; IN 396191
• MDR Report Key: 7064464
• Report Number: 3009613036-2017-00004
• Device Sequence Number: 16339260
• Product Code: LOX
• UDI-Device Identifier: 18904224907697
• UDI-Public: 18904224907697
• 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
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 11/28/2017

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: 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
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/01/2017
• Initial Report FDA Received Date: 11/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 79 YR