MAUDE Adverse Event Report: CORDIS CASHEL MAXI LD 7F 18X4 80CM; DILATOR, ESOPHAGEAL

Model Number	4171840S
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/06/2017
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 the maxi ld balloons catheters burst at two atmospheres (2 atms).There were no patient injury.The device will not be returned for analysis.
Additional Manufacturer Narrative
This is one of two products involved with the reported event.The manufacturing reference number for this event is (b)(4).The manufacturing reference number for the other complaint is (b)(4).It was reported that the maxi ld balloons catheters burst at two atmospheres (2 atms).There were no patient injury.The device was not returned for analysis.A device history record (dhr) review of lot 17632308 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¿ could not be confirmed as the devices were not returned for analysis.The exact cause of the bursts could not be determined.Based on the limited information available for review, vessel characteristics (although not provided) may have contributed to the reported event as calcification/resistant lesions may cause damage to a balloon.According to the instructions for use, which is not intended as a mitigation, ¿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 nor the information available suggests a design or manufacturing related cause for the reported event.Therefore, no corrective/preventive action will be taken at this time.

• Brand Name: MAXI LD 7F 18X4 80CM
• Common Device Name: DILATOR, ESOPHAGEAL
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, tipperary 32575 ; EI 32575
• MDR Report Key: 6755630
• Report Number: 9616099-2017-01278
• Device Sequence Number: 652913
• Product Code: KNQ
• UDI-Device Identifier: 20705032002605
• UDI-Public: 20705032002605
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K023907
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/09/2017

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: 06/30/2018
• Device Model Number: 4171840S
• Device Catalogue Number: 4171840S
• Device Lot Number: 17632308
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 07/06/2017
• Initial Date Received by Manufacturer: 07/06/2017
• Supplement Date Received by Manufacturer: 08/08/2017
• Initial Report FDA Received Date: 07/31/2017
• Supplement Report FDA Received Date: 08/09/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1