(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Evaluation summary: visual and functional inspections were performed on the returned device.The reported cracks were confirmed; however, the reported loose or intermittent connection could not be confirmed.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other similar incidents from this lot.The investigation was unable to determine a conclusive cause for the reported loose or intermittent connection; however, the reported cracks appear to be related to operational context.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.
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It was reported that a 2.0x20mm mini trek dilatation catheter was advanced to the proximal left anterior descending (lad), 75% stenosed lesion without issue.The mini trek was unable to connect to an unspecified indeflator.It was then noted that the mini trek hub cracked.There was no leakage or air entrapment noted.The mini trek was removed from the anatomy without reported issue and a new device was used successfully with the same indeflator.The procedure was completed successfully.There were no adverse patient effects and there was no clinically significant delay.There were no other device issues.There was no additional information provided regarding this device.During abbott vascular's analysis of the returned mini trek, the device was securely attached to a proxy indeflator and an attempt was made to pressurize the balloon catheter to balloon nominal pressure of 8 atmospheres, when fluid leaked out of the cracks noted in the hub and the balloon could not be inflated.
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