MAUDE Adverse Event Report: CORDIS DE MEXICO POWERFLEXPRO 7MM2CM 135; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	4400702X
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/21/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was not returned for analysis. device history record (dhr) review was conducted and the product met quality requirements for product acceptance.Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
It was reported that a power flex pro balloon catheter ruptured.The device was replaced with a new power flex pro and the procedure was completed successfully.There was no reported patient injury.A non-cordis 6f sheath introducer was inserted and a non cordis 0.35 guidewire crossed the lesion.A 7*8 smart stent was deployed in the lesion and a power flex pro was delivered to the lesion for a post-dilatation.However it ruptured at 8 atm.The target lesion was unknown.The patient¿s vessel level of tortuousness and calcification was unknown.The rate of stenosis was unknown.The product was clinically used and will not be returned for analysis.The device prep normally and according to the instruction for use (ifu).There were no damages noted to the device packaging.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.The product was removed intact (in one piece) from the patient.No other information was provided.
Additional Manufacturer Narrative
It was reported that a 7 x 20 mm 135 cm powerflex pro balloon catheter ruptured at eight atmospheres (8 atm).The device was replaced with a new power flex pro and the procedure was completed successfully.There was no reported patient injury.A non-cordis 6f sheath introducer was inserted and a non cordis 0.35 guidewire crossed the lesion.A 7*8 smart stent was deployed in the lesion and a power flex pro was delivered to the lesion for a post-dilatation.However it ruptured at 8 atm.The target lesion was unknown.The patient¿s vessel level of tortuousness and calcification was unknown.The rate of stenosis was unknown.The device prep normally and according to the instruction for use (ifu).There were no damages noted to the device packaging.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.The product was removed intact (in one piece) from the patient.No other information was provided.The device was not returned for analysis.A device history record (dhr) review of lot 17049263 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿balloon burst-at/below rbp (peripheral)¿ could not be confirmed as the device was not returned for analysis.The exact cause could not be determined.Vessel characteristics (although unknown) may have contributed to the reported event.According to the instructions for use: ¿the rated burst pressure is based on the results of in-vitro testing.At least 99.9% of the balloons (with a 95% confidence), will not burst at or below their rated burst pressure.Use of a pressure monitoring device is recommended to prevent over pressurization.¿ neither the dhr nor the information available suggests a design or manufacturing related cause for the reported event; therefore, no corrective/preventive action will be taken.

• Brand Name: POWERFLEXPRO 7MM2CM 135
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS DE MEXICO; circuito int nte 1820; juarez 32575 ; MX 32575
• MDR Report Key: 6496972
• Report Number: 9616099-2017-01036
• Device Sequence Number: 16303847
• Product Code: LIT
• UDI-Device Identifier: 20705032059678
• UDI-Public: 20705032059678
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 04/20/2017

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: 05/31/2017
• Device Model Number: 4400702X
• Device Catalogue Number: 4400702X
• Device Lot Number: 17049263
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 03/21/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/21/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/17/2017
• Supplement Report FDA Received Date: 04/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1