MAUDE Adverse Event Report: CORDIS DE MEXICO MAXI LD PTA F7 110 15X40; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	4161540L
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/03/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).A device history record review was performed and showed that these lots of products met all requirements per the applicable manufacturing quality plan. this device is available for analysis but the engineering report is not yet available.  however, it will be submitted within 30 days upon receipt.
Event or Problem Description
It was reported that the maxi ld f7 110 15x40 balloon catheter ruptured.The procedure was successfully completed using another maxi ld.There was no patient injury.The device prep normally.There were no difficulties removing the product from the hoop, the protective balloon cover, the stylet or any of the sterile packaging components.There were no kinks or other damages noted prior to inserting the product into the patient.The product was removed intact (in one piece) from the patient.There was no resistance/friction while inserting the balloon through the rotating hemostatic valve, the guide catheter, or the vessel.There was no difficulty crossing the lesion.The catheter has never been in an acute bend. the target lesion is the iliac artery. the intended procedure is the iliac artery occlusion.The contrast media used was bayer with a contrast to saline ratio 1:1.The type and brand of inflation device used was mmsi which was used successfully with other devices.
Additional Manufacturer Narrative
It was reported that the maxi ld f7 110 15x40 balloon catheter ruptured.The procedure was successfully completed using another maxi ld.There was no patient injury.The target lesion is the iliac artery.The intended procedure is the iliac artery occlusion.The device prep normally.The contrast media used was bayer with a contrast to saline ratio 1:1.The type and brand of inflation device used was mmsi which was used successfully with other devices.There were no difficulties removing the product from the hoop, the protective balloon cover, the stylet or any of the sterile packaging components.There were no kinks or other damages noted prior to inserting the product the product into the patient.There was no resistance/friction while inserting the balloon through the rotating hemostatic valve, the guide catheter, or the vessel.There was no difficulty crossing the lesion.The catheter has never been in an acute bend.The product was removed intact (in one piece) from the patient.A non-sterile unit of maxi ld pta f7 110 15x40 was received coiled inside a plastic bag.Per visual analysis, an axial balloon burst of 5.5 cm in length was observed at 1.6cm from distal end.Blood residues were observed on the received maxi catheter.No other anomalies/damages were observed in the device.Leak test could not be performed due to axial burst found on balloon during the visual analysis.Unit was sent to sem analysis and results showed that the external surface presented evidence of scratches and abrasion marks near to the balloon axial burst condition.It is very likely that the same factors that caused the scratch marks on the balloon¿s outer surface could have also contributed to the axial burst condition found on the received balloon.The internal surface and marker bands did not presented any evidence of damages.No other anomalies were found during the analysis.A device history record (dhr) review of lot 17397132 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿balloon-burst¿ was confirmed through analysis of the device received.However, the exact cause of the rupture condition of the balloon could not be conclusively determined during analysis.Based on the limited information available for review, vessel characteristics (although not provided) may have contributed to the rupture reported as evidenced by the scratch marks and abrasions noted on the balloon during analysis.According to the instructions for use (ifu), ¿the rated burst pressure is printed on the package label.In vitro testing has shown that with 95% confidence, 99.9% of the balloons will not burst at or below the rated pressure.Balloons should not be inflated in excess of the rated burst pressure.¿ neither the dhr review nor the product analysis suggests that the event experienced by the customer could be related to the manufacturing process.Therefore, no corrective/preventive action will be taken.

• Brand Name: MAXI LD PTA F7 110 15X40
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS DE MEXICO; circuito int nte 1820; juarez 32575 ; MX 32575
• MDR Report Key: 6536620
• Report Number: 9616099-2017-01064
• Device Sequence Number: 1202204
• Product Code: LIT
• UDI-Device Identifier: 20705032002131
• UDI-Public: 20705032002131
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K963000
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/12/2017

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: 06/30/2017
• Device Model Number: 4161540L
• Device Catalogue Number: 4161540L
• Device Lot Number: 17397132
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2017
• Distributor Facility Aware Date: 04/05/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/05/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/02/2017
• Supplement Report FDA Received Date: 05/12/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Weight: 72