MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES 4F-80CM PREM SYNTEL CATHETER; DXE

Model Number	10
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/09/2014
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: the event unit was returned for evaluation.Upon inspection engineering confirmed that the catheter was damaged.The catheter had a radial ruptured balloon close to the proximal winding.The balloon's distal and proximal windings, along with the balloon itself were still attached to the catheter shaft.The catheters are designed in such a way that the proximal winding will slip or the balloon will burst under excessive force.This design prevents the force from being applied to the catheter body and breaking inside the patient and also prevents excessive force from being applied to the vessel itself.It is unclear at what actual volume the balloon rupture had occurred.It is unknown under what conditions and with what type of equipment or instruments the catheter may have come into contact.Applied medical instructions for use (ifu) cautions the user that balloon degradation and rupture may result from exposure to adverse environmental conditions, excessive handling, or deposits within the vessel.This report is being filed as a result of a re-review of applied medical complaints received between june 1, 2014 and may 31, 2016.  this retrospective review was associated with a quality management system (qms) compliance action plan developed and presented to fda to address an april 10, 2015 warning letter.Applied medical has revised its mdr reporting criteria to be more conservative and has improved complaint handling and mdr reporting processes.The reviews ensured that recent reportable events were appropriately identified and reported to the designated regulatory authority(ies).This report, which represents the initial and final reports combined, is being submitted based on the findings of that retrospective review.In accordance to 21 cfr 803.56, if additional information is obtained which was not known or was not available when this report was submitted, then a supplemental report will be submitted to the fda.
Event or Problem Description
Procedure performed unknown - "burst of the balloon.The doctor mentioned that there is no calcification on the patient which can explain the balloon.From e-mail confirmation: burst of the balloon.The doctor mentioned that there is no calcification on the patient, which could explain the burst of the balloon." patient status - ok.

• Brand Name: 4F-80CM PREM SYNTEL CATHETER
• Common Device Name: DXE
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 6382144
• Report Number: 2027111-2017-01353
• Device Sequence Number: 16312340
• Product Code: DXE
• UDI-Device Identifier: 00607915117528
• UDI-Public: (01)00607915117528(17)190127(30)01(10)1214525
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: 10
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/06/2017

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: Other
• Device Expiration Date: 01/27/2019
• Device Model Number: 10
• Device Catalogue Number: 10
• Device Lot Number: 1214525
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2014
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/11/2014
• Initial Report FDA Received Date: 03/06/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1