This mdr is being submitted as part of retrospective review as a result of a recent fda audit and with accordance to the requirements of code of federal regulations ¿ 21 cfr part 803, medical device reporting.This is report 2 of 2 for (b)(4).The complaint received states that during use two balloons burst during prep, ascent balloon catheter 6 mm x 9 cm (brs00060900 / unk & brs000407-00 / unk).Balloons to be used in balloon test occlusion test.Before using prepped on back table both balloons popped while trying to prep.Exam was cancelled and was rescheduled.Account called me and i went in next day to in-service on prep again.There is no report of injury for the patient.Fal: observations: balloon catheter 6x9 f60880: no defects were found during the catheter outer surface inspection except on the balloon area where a longitudinal teat from the proximal seal to the distal seal was found.The length of the tear is 12mm approximately.Balloon catheter 4x7 f38920: no defects were found during the catheter outer surface inspection except on the balloon area where a longitudinal teat from the proximal seal to the distal seal was found.The length of the tear is 16mm approximately.In both cases, the longitudinal tear was found from the proximal deal to the distal seal.This is an indication that the balloons were over inflated which resulted in stretching the balloon and possibly led to rupture.The complaint was confirmed on analysis.100% inspections are in place to prevent damaged products from leaving the facility and the dhr review confirmed that the product met specifications.No corrective action is required at this time.Review of the information suggests that procedural and handling issues may have contributed to the reported events and confirmed damage to the devices.
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